Abstract
Background:
Flavored novel oral nicotine products (ONP), such as pouches, gum, lozenges, tablets, and gummies, have recently entered the US market but have not been authorized for smoking cessation. This study assessed the prevalence and correlates of ONPs in a national sample of youth who smoked little filtered cigars or cigarillos (LCCs) or were susceptible to LCCs.
Methods:
We conducted a national online survey from September-October 2022, as part of a study to develop cigar warnings among youth. Those aged 15-20 years old who reported using (ever or current) or susceptibility to little filtered cigars or cigarillos (LCCs) were eligible. Descriptive statistics and chi-square analyses assessed the prevalence of flavored ONP use and associations with other past 30-day tobacco product use and participant characteristics.
Results:
Approximately one-fifth (17.1%) of the sample (n=680) reported past month flavored ONP use. Any past month tobacco use was correlated with past month flavored ONP use (ps<.001), increasing from 17.1% in the overall sample to 26.8% among those reporting e-cigarette use, 41.4% (LCCs), 47.8% (waterpipe tobacco), 61.8% (large cigars), and 69.1% (smokeless tobacco). The number of products used in the past month was significantly associated with higher odds of ONPs in the past month in a multivariable logistic regression model (aOR: 2.26; 95% CI: 1.92, 2.65).
Discussion:
Almost one-fifth of participants who use or are susceptible to cigar use in our national sample of youth use ONPs. Dual/poly use of other tobacco products and ONPs among youth suggests that many of these youth may be addicted to nicotine. Additional surveillance and regulation of ONPs that exhibit enticing characteristics, such as flavors, kid-friendly formulations, and targeted marketing/branding may be needed.
Keywords: youth, tobacco, oral nicotine
Introduction
The market for non-combusted nicotine products has expanded exponentially in recent years, with options including disposable and non-disposable e-cigarettes, non-smoked or pasteurized tobacco (e.g., snus), and more. Many of these products are particularly popular among youth and young adults,1 including a new class of recreational oral nicotine products (ONPs), many of which use synthetic nicotine (i.e., not derived from tobacco). This includes commercial nicotine products such as pouches, lozenges, tablets, gummies, and gum, which have not been approved for therapeutic purposes.2 These products, particularly nicotine pouches, are gaining market share among non-combusted products.3 While ONPs share some characteristics with medicinal oral nicotine replacement therapy (e.g., formulations such as gum and lozenges), they are not approved cessation products and exhibit characteristics that appeal to youth, such as flavors, kid-friendly formulations (e.g. gum, gummies), and marketing/branding targeted towards this age group.4,5
In April 2022, Harlow and colleagues published the first data on the use prevalence of these novel ONPs (e.g., gummies, lozenges, tablets, pouches) from a 2021 regional sample of high schoolers in Southern California. ONPs were the second most prevalent nicotine product used among youth after e-cigarettes, with 3.4% of students reporting ever use and 1.7% reporting past six-month use.2. Furthermore, ONP use was associated with previous tobacco use (any combusted or noncombusted product), Hispanic ethnicity, and LGBTQ+ status. Similar characteristics, in addition to low socioeconomic status, were also associated with susceptibility to ONPs in a sample of Californian high schoolers who had never used tobacco products.6 Additionally, data from a sample of youth in California indicate that adolescents are more willing to use ONPs compared to traditional forms of smokeless tobacco.5 A 2021 national convenience survey found that 20.9% of 13-20-year-old respondents ever used ONPs, as well as 12.1% in the past 30 days and 10.2% in the past seven days.4 In response to these data, the Food and Drug Administration (FDA) issued warning letters to several ONP companies and now prohibits the marketing of any non-tobacco nicotine product that has not received pre-market authorization.7,8 Since Harlow’s study was published, some products are no longer on the market (e.g., Krave Nicotine Gummies). To date, however, these novel ONPs are not widely assessed in large nationally-representative surveys, with the exception of nicotine pouches (but not other ONPs) in the Population assessment of Tobacco and Health (PATH) and the National Youth Tobacco Survey (NYTS). The 2023 NYTS survey reported that, among high school students, 3.1% reported past 30 day use of nicotine pouches, and 3.5% for other oral nicotine products.9 Among middle school students, 2.2% reported past 30 day use of other oral nicotine products.10
A greater understanding of youth use of these novel ONPs is needed. In particular, it is important to examine the potential use and correlates of use among youth who report using tobacco products or are at risk of using other tobacco products. In 2022, cigars became the most commonly used combusted tobacco product among youth, surpassing cigarettes, remaining high among high school students in 2023.9,11 Therefore, focusing on those who use or are susceptible to smoking cigars is of particular importance. Consistent associations of ONP use with use of other nicotine/tobacco products6,12 could represent substitution (e.g. using e-cigarettes instead of combusted cigarettes in an attempt to cut down on combusted cigarettes) or dynamic complementary use (using multiple tobacco products for different reasons or purposes).13,14 Multiple tobacco product use is common in youth11 who also display variable transitions between products in longitudinal studies.15 Youth may also use ONPs with the intent of quitting other nicotine/tobacco products. Preliminary evidence from Leventhal and colleagues (2022) indicates that this may not be the case.16 When exposed to images of ONPs, intention to try among 20-24 year-olds who used e-cigarettes but not ONPs did not differ by e-cigarette quit motivation.16 However, among those who used e-cigarettes, some believe that use of these novel ONPs could help them reduce or quit vaping.17 Given the popularity of cigars among youth as a form of tobacco product use, it is important to examine the use and reasons for use of flavored novel ONP among those who smoke cigars or might be susceptible to cigar smoking.
Despite the importance of better understanding flavored novel ONP use, especially with regard to the full spectrum of nicotine/tobacco products, the most current nationally representative ONP prevalence estimates published is from NYTS, with limited other nationally representative estimates published or focused only on nicotine pouches.10 Additionally, previous studies have not assessed associations between novel ONPs and current use of other tobacco products, such as cigarettes, cigars, and waterpipe tobacco. The current study assessed the prevalence and correlates of flavored novel ONPs in a national sample of youth.
Methods
Data were collected as part of a study to develop pictorial warnings for cigars that are effective among youth. Qualtrics recruited a final sample of 680 participants from September – October 2022. Qualtrics has access to vendors with existing panels for social science research and a platform for online surveys. To be eligible for participation, participants had to be between the ages of 15-20, speak English, live in the United States, and report past 30-day use, ever use, or be susceptible to using little cigars or cigarillos. Susceptibility was defined as responding anything but “definitely not” to one of four questions comprising a susceptibility scale (e.g., If one of your best friends were to offer you a cigarillo or little cigar, would you smoke it?).18 This age group was selected and defined as “youth” because 21 is the minimum legal sales age for tobacco in the United States.
We obtained consent for 18–20-year-olds. For 15–17-year-olds, we obtained both youth assent and parental or legal guardian consent. The University of North Carolina and Chapel Hill Institutional Review Board approved the study.
Measures
The survey first assessed age, race, ethnicity, and cigar use and susceptibility in the screener. After our main study items, participants were asked about their use of other tobacco products, including flavored novel ONPs. Finally, the survey assessed additional demographic questions.
Little Filtered Cigar and Cigarillo Use and Susceptibility.
In the screener survey, to determine study eligibility, participants were provided a definition, along with example brand names and images, for both cigarillos and little cigars (assessed separately). Participants were asked if they had ever smoked cigarillos or little cigars. If they reported yes, they were then asked how many of the past 30 days they smoked a cigarillo or little cigar. For those who reported that they had never smoked cigarillos and little cigars, we assessed susceptibility with four items adapted from an established susceptibility measure.19 Participants who reported with anything other than “definitely not” to at least one of the four times was classified as susceptible to little filtered cigars/cigarillos.
Novel Oral Nicotine Product Use.
All participants were asked “In the past 30 days, which of the following nicotine products have you used at least once?” with example brands provided.2 Participants could check all that applied from the following options: flavored nicotine gum; flavored nicotine lozenges; flavored nicotine tablets; flavored nicotine gummies; flavored nicotine pouches; or none of the above (exclusive).
Other Tobacco Products.
Participants were asked if they had ever smoked a large, traditional cigar, and if so, how many times in the past 30 days (with images and example brands). We also asked participants to select which of the following products that they used at least once in the past 30 days with a single survey item: cigarettes, smokeless tobacco (for example, chewing tobacco, snuff, dip, snus), e-cigarettes or other vaping devices, waterpipe tobacco or hookah, or none of the above (exclusive).
Demographics.
We assessed a variety of participant characteristics, including age, racial identity, Hispanic/Latino ethnicity, gender identity, sexual orientation, and grade. See Table 1 for categories and response options.
Table 1.
Participant Characteristics, N=680
| Characteristic | N (%) |
|---|---|
| Gender Identity | |
| Man or boy | 225 (33.1%) |
| Woman or girl | 382 (56.2%) |
| Gender neutral | 13 (1.9%) |
| Non binary | 35 (5.2%) |
| Gender queer | 8 (1.2%) |
| Two-spirit | 5 (0.7%) |
| None of these describe me | 2 (0.3%) |
| Prefer not to answer | 10 (1.5%) |
| Sexual orientation | |
| Straight | 425 (62.5%) |
| Lesbian or gay | 42 (6.2%) |
| Bisexual | 154 (22.7%) |
| Something else | 34 (5.0%) |
| I am not sure yet | 21 (3.1%) |
| I do not know what this question means | 4 (0.6%) |
| Race | |
| White | 383 (56.3%) |
| Black or African American | 133 (19.6%) |
| Asian | 31 (4.6%) |
| American Indian or Alaska Native | 17 (2.5%) |
| Middle Eastern or North African | 8 (1.2%) |
| Native Hawaiian or Pacific Islander | 3 (0.4%) |
| Some other race, ethnicity or origin not listed | 42 (6.2%) |
| More than one race | 51 (7.5%) |
| Prefer not to answer | 12 (1.8%) |
| Hispanic or Latino | |
| No | 511 (75.2%) |
| Yes | 161 (23.7%) |
| Don’t know | 8 (1.2%) |
| Age | |
| 15-17 | 179 (26.3%) |
| 18-20 | 501 (73.7%) |
| Grade | |
| Not in school | 211 (31.0%) |
| 8th, 9th, 10th | 34 (5.0%) |
| 11th, 12th | 171 (25.2%) |
| College | 237 (34.9%) |
| Home-schooled | 13 (1.9%) |
| School is ungraded | 14 (2.1%) |
| Tobacco/e-cigarette product usea | |
| No past 30-day tobacco/e-cigarette product use | 324 (47.7%) |
| Past 30-day tobacco/e-cigarette product use | 356 (52.4%) |
| Number of tobacco products used in the past 30 days, a mean (SD) | 1.13 (1.47) |
excludes novel oral nicotine products (e.g., lozenges, gummies; ONPs)
Data analysis
We first examined descriptively the prevalence of past 30-day flavored novel ONP use, creating a variable for any vs. no product use. We then conducted chi-square analyses to examine whether past 30-day ONP use was associated with 1) past 30-day tobacco product use (any use; use of specific products; and number of products used) and 2) participant characteristics. Finally, we conducted a multivariable logistic regression model examining associations between number of tobacco products used, participant characteristics, and past 30-day ONP use. We used number of tobacco products, rather than any tobacco product use, because only six participants reported not using any tobacco product and reported using ONP, which led to unstable estimates. For the logistic regression model, results include adjusted odds ratios (aORs) and 95% confidence intervals (CIs); we interpreted nonoverlapping confidence intervals as statistically significant. Analyses for this study were conducted with SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). We set critical α = .05 and used 2-tailed statistical tests.
Results
Participant characteristics
Most participants in our sample (N=680) were between the ages of 18-20 (73.7%) (Table 1). Around half of the sample identified as white (56.3%), a woman or girl (56.2%), and straight (62.5%). Additionally, approximately half of the sample reported any past 30-day tobacco product use (52.4%).
Oral nicotine product use
Almost one-fifth of the sample (17.1%) reported using any flavored novel ONP in the past 30 days, with the most reported products being gum (6.2%), gummies (4.4%), and lozenges (3.7%) (Table 2).
Table 2.
Past 30-Day Use of Flavored Novel Oral Nicotine Products, N=680
| Product | N (%) |
|---|---|
| Nicotine Gum | 42 (6.2%) |
| Nicotine Gummies | 30 (4.4%) |
| Nicotine Lozenges | 25 (3.7%) |
| Nicotine Tablets | 21 (3.1%) |
| Nicotine Pouches | 21 (3.1%) |
| Combined (# of participants) | 116 (17.1%) |
| Combined (mean # of products) among people who reported using at least one product | M: 1.20; SD: 0.42; Range: 1-3 |
Correlates of oral nicotine product use
Results show that past 30-day tobacco use was highly correlated with past 30-day flavored novel ONP use (all p <0.001, Table 3). For instance, prevalence of past 30-day flavored novel ONP use in the entire sample was 17.1%, with higher prevalence among those reporting e-cigarette use (26.8%), 34.6% among those reporting cigarette use, 41.4% among those reporting cigarillo use, 47.8% among those reporting waterpipe tobacco use, 48.9% among those reporting little cigar use, 61.8% among those reporting large cigar use, and 69.1% among those reporting smokeless tobacco use (excluding novel ONPs). Among participants who did not use other tobacco products in the past 30 days, the prevalence of past 30-day flavored novel ONP use was 1.9%. Past 30-day flavored novel ONP use was also significantly associated with the number of tobacco products used in the past 30 days. Specifically, those reporting past 30-day flavored novel ONP use reported using 2.72 (SD: 1.67) tobacco products, on average, while those reporting no past 30-day flavored novel ONP use reported using 0.81 (SD:1.19) tobacco products, on average. For demographics, age was significantly associated with past 30-day flavored novel ONP use, with a higher prevalence among 18–20-year-olds (19.2%) compared with 15-17-year-olds (11.2%); no other demographic associations were statistically significant (Table 4).
Table 3.
Association of Past 30-Day Flavored Novel Oral Nicotine Product Use with Past 30-Day Use of Other Tobacco Products, N=680
| Tobacco Product (Past 30-Day Use) | No Past 30-Day Oral Nicotine Use N (%) |
Past 30-Day Oral Nicotine Use N (%) |
p a |
|---|---|---|---|
| Any tobacco useb | |||
| No | 318 (98.2%) | 6 (1.9%) | <0.001 |
| Yes | 246 (69.1%) | 110 (30.9%) | |
| E-cigarettes | |||
| No | 395 (88.0%) | 54 (12.0%) | <0.001 |
| Yes | 169 (73.2%) | 62 (26.8%) | |
| Cigarettes | |||
| No | 494 (86.2%) | 79 (13.8%) | <0.001 |
| Yes | 70 (65.4%) | 37 (34.6%) | |
| Cigarillos | |||
| No | 462 (91.3%) | 44 (8.7%) | <0.001 |
| Yes | 102 (58.6%) | 72 (41.4%) | |
| Waterpipe tobacco | |||
| No | 540 (85.2%) | 94 (14.8%) | <0.001 |
| Yes | 24 (52.2%) | 22 (47.8%) | |
| Little cigars | |||
| No | 516 (88.1%) | 70 (12.0%) | <0.001 |
| Yes | 48 (51.1%) | 46 (48.9%) | |
| Large cigars | |||
| No | 535 (88.6%) | 69 (11.4%) | <0.001 |
| Yes | 29 (38.2%) | 47 (61.8%) | |
| Smokeless tobacco | |||
| No | 551 (86.4%) | 87 (13.6%) | <0.001 |
| Yes | 13 (31.0%) | 29 (69.1%) | |
| Number of tobacco products used, mean (SD) | 0.81 (1.19) | 2.72 (1.67) | <0.001 |
p-values come from chi-square analyses that were not adjusted for any other variables.
Excludes flavored novel oral nicotine products
Table 4.
Demographic Associations with Past 30-Day Flavored Novel Oral Nicotine Product Use, N=680
| No Past 30-Day ONP Use N (%) |
Past 30-Day ONP Use N (%) |
p e | |
|---|---|---|---|
| Gender Identity | 0.10 | ||
| Man or boy | 191 (84.9%) | 34 (15.1%) | |
| Woman or girl | 308 (80.6%) | 74 (19.4%) | |
| Other a | 57 (90.5%) | 6 (9.5%) | |
| Sexual orientation | 0.66 | ||
| Straight | 347 (81.7%) | 78 (18.4%) | |
| Lesbian or gay | 35 (83.3%) | 7 (16.7%) | |
| Bisexual | 132 (85.7%) | 22 (14.3%) | |
| Other b | 47 (85.5%) | 8 (14.6%) | |
| Race | 0.09 | ||
| White | 321 (83.8%) | 62 (16.2%) | |
| Black or African American | 105 (79.0%) | 28 (21.1%) | |
| Asian | 25 (80.7%) | 6 (19.4%) | |
| Other c | 54 (77.1%) | 16 (22.9%) | |
| More than one race | 48 (94.1%) | 3 (5.9%) | |
| Hispanic | 0.82 | ||
| No | 426 (83.4%) | 85 (16.6%) | |
| Yes | 133 (82.6%) | 28 (17.4%) | |
| Age | 0.01 | ||
| 15-17 | 159 (88.8%) | 20 (11.2%) | |
| 18-20 | 405 (80.8%) | 96 (19.2%) | |
| Grade | 0.18 | ||
| Not in school | 172 (81.5%) | 39 (18.5%) | |
| 8th, 9th, 10th | 32 (94.1%) | 2 (5.8%) | |
| 11th, 12th | 148 (86.6%) | 23 (13.5%) | |
| College | 191 (80.6%) | 46 (19.4%) | |
| Other d | 21 (77.8%) | 6 (22.2%) |
Gender neutral (n=13); non binary (n=35); gender queer (n=8); two-spirit (n=5); none of these describe me (n=2)
Something else (n=34); I am not sure yet (n=21)
American Indian or Alaska Native (n=17); Native Hawaiian or Pacific Islander (n=3); Middle Eastern or North African (n=8); some other race, ethnicity or origin not listed (n=42)
Home-schooled (n=13); school is ungraded (n=14)
p-values come from chi-square analyses that were not adjusted for any other variables.
Boldface denotes statistical significance at p<0.05.
Finally, in the multivariable logistic regression model, number of tobacco products used in the past 30 days was significantly associated with higher odds of past 30-day flavored novel ONP use (adjusted odds ratio: 2.26; 95% CI: 1.92, 2.65) and bisexual youth had lower odds of past 30-day flavored novel ONP use compared with straight youth (adjusted odds ratio: 0.48; 95% CI: 0.25, 0.94) (Table 5). No other participant characteristics were significantly associated with past 30-day flavored novel ONP use.
Table 5.
Logistic Regression Examining the Associations between Number of Tobacco Products Used and Participant Characteristics on Past 30-Day Flavored Novel Oral Nicotine Product Use, N=680
| Past 30-Day ONP Use aOR (95% CI) |
|
|---|---|
| Number of tobacco products used | 2.26 (1.92, 2.65) |
| Gender Identity | |
| Man or boy | Ref. |
| Woman or girl | 1.61 (0.92, 2.85) |
| Other | 1.21 (0.38, 3.88) |
| Sexual orientation | |
| Straight | Ref. |
| Lesbian or gay | 0.74 (0.28, 1.97) |
| Bisexual | 0.48 (0.25, 0.94) |
| Other | 0.85 (0.30, 2.42) |
| Race | |
| White | Ref. |
| Black or African American | 1.38 (0.76, 2.49) |
| Asian | 2.14 (0.71, 6.40) |
| Other | 1.31 (0.57, 3.00) |
| More than one race | 0.31 (0.07, 1.44) |
| Hispanic | |
| No | Ref. |
| Yes | 1.19 (0.64, 2.22) |
| Age a | |
| 15-17 | Ref. |
| 18-20 | 0.96 (0.51, 1.81) |
Grade was not included as a participant characteristic in this model given the overlap between grade and age.
Boldface denotes statistical significance at p<0.05.
Discussion
In this national sample of youth ages 15-20 who reported using or susceptibility to use LCCs, 17% reported past 30-day use of flavored novel ONPs, such as gummies, gum, lozenges, tablets, and pouches. Additionally, we found that use of these flavored novel ONPs was highly correlated with using other tobacco products and being older (i.e., 18-20 vs. 15-17), but not with most other sociodemographic factors.
Poly tobacco use among youth is common,11 but our understanding of patterns of poly tobacco use with flavored novel ONPs is limited. Data from the 2022 National Youth Tobacco Survey show that 5% of high school students use multiple tobacco products.11 The prevalence of poly tobacco use in our sample was higher, with approximately one-third of those who reported past 30-day use of flavored novel ONPs reporting past 30 day use of at least one other tobacco/nicotine product. However, this higher prevalence is expected because our sample included older participants and only included those who used or were susceptible to use LCCs. A longitudinal analysis of the National Youth Tobacco Survey identified that dual use of e-cigarettes with cigars increased significantly from 2011-2020,20 indicating that youth who use cigars are likely to use other tobacco/nicotine products, which could now include flavored novel ONPs. Data also show that cigar use predicts initiation of other tobacco/nicotine products among youth, including cigarettes.21 Furthermore, we found that the overlap between those reporting both smokeless tobacco and flavored novel ONP use was high, with 69% of those who used flavored novel ONPS in the past 30 days also using smokeless tobacco in the past 30 days. This may be due to flavored novel ONPs also being a non-combusted or smokeless product that is consumed orally. It is also possible that the survey items (smokeless and ONPs) may be misinterpreted as being the same nicotine/tobacco product. However, our findings align with recent national data identifying high co-use between nicotine pouches (a type of flavored novel ONP) and smokeless tobacco.22 Interestingly, those reporting past 30-day flavored novel ONP use reported using a higher number of tobacco/nicotine products compared to those who did not report past 30-day use. Additional surveillance of new tobacco products and how they may alter young people’s tobacco use patterns is important to monitor.
Much of the flavored novel ONPs on the market are not derived from tobacco, but still contain nicotine, which could result in addiction among youth and experimentation with other combusted forms of tobacco products, such as cigarettes or cigars. Although flavored novel ONP may not present the same harms as combusted tobacco products or contain the same constituents,23 it is important to continue surveilling use, including longitudinal patterns and initiation of other products or substances. Additionally, because the nicotine and tobacco landscape continues to rapidly evolve, research on marketing and selling strategies used by the tobacco/nicotine industry are needed to inform regulations.24 Because these are new products, young consumers generally are unsure of their harms,25 so efforts to inform people of the risks of these products and their potential for addiction are critical. Additionally, a better understanding of why youth are using these products is needed. Research has begun to identify reasons for use. In one study, 44% of young adults who use e-cigarettes and are motivated to quit reported interest in using ONPs to quit/reduce vaping compared to other traditional quitting methods, such as prescription medications, medicinal nicotine gum/lozenges, and the nicotine patch. Furthermore, interest in trying ONPs among young adults who use e-cigarettes was higher compared to those who do not use e-cigarettes, including among those not motivated to quit.17 Future research should further explore reasons for use of these products among youth.
Limitations of our study include that this was a sample of youth who reported LCC use or susceptibility to use, so flavored novel ONP prevalence estimates are likely higher compared to nationally-representative samples that include non-users who are not susceptible to LCC use – which is likely to characterize most youth. However, given that cigars are one of the most frequently used combusted tobacco products, this study helps us begin to understand use among those who smoke cigars or are susceptible to future cigar use, which is important for monitoring efforts. Additionally, we did not assess reasons for using these products. It is possible that youth may be trying these products for a variety of reasons, including help with quitting other forms of nicotine or tobacco, the products are easy to access, use is easily concealed, youth are exposed to marketing, and the products come in appealing flavors and formulations (e.g., gummies). Related, we did not assess nicotine dependence, which could have provided some insight into reasons for use. Research has begun to identify that reasons for ONP use among young adults may depend on tobacco/nicotine product use status.17 Another limitation is that we are unable to assess which tobacco or nicotine product youth reported using first, which may provide insights into longitudinal trajectories and transitions of use. However, the presence of these additional products on the market provides youth with additional opportunities to experiment with tobacco or nicotine products.26
Conclusion
Among youth who reported using or susceptibility to LCCs, we found that almost one-fifth reported past 30-day use of flavored novel ONPs. We also found that use of these flavored novel ONPs were strongly associated with use of other tobacco and nicotine products, highlighting the need for continued monitoring.
Highlights.
Flavored novel oral nicotine products are increasing in the commercial tobacco product market.
Almost 1 in 5 youth reported past month use of flavored novel oral nicotine products.
Past month use of any other tobacco product was strongly correlated with past month use of flavored novel oral nicotine products.
New products may encourage youth continued use and addiction.
Declaration of interests:
Research reported in this abstract was supported by NCI and FDA Center for Tobacco Products (CTP) under award number R01CA260822. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration. DR was supported by the NIH Clinical and Translational Science Award (CTSA), TL1TR002553.
All authors are supported by multiple NIH-funded grants.
Footnotes
Publisher's Disclaimer: 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.
Conflict of Interest: none to report
CRediT Author Statement
JCR: Conceptualization, methodology, investigation, writing-original draft, writing-reviewing & editing, supervision, project administration, funding acquisition; SDK: conceptualization, methodology, investigation, formal analysis, visualization, writing-reviewing & editing; DR: conceptualization, writing-original draft, writing-reviewing & editing; KLJ: conceptualization, methodology, investigation, writingreviewing & editing, project administration; AOG: writing-reviewing & editing; JFT: writing-reviewing & editing; LMR: Conceptualization, methodology, investigation, writing-reviewing & editing, supervision, project administration, funding acquisition
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