d -Amphetamine Transdermal System in Treatment of Children and Adolescents With ADHD: SKAMP Subscale Analysis and Subgroup Analysis from a Pivotal Trial

Abstract

Objectives:

d-Amphetamine transdermal system (d-ATS) is FDA-approved for treating attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients ≥6 years. In a pivotal study, d-ATS met its primary (SKAMP total score) and secondary endpoints. This analysis further evaluated d-ATS efficacy using SKAMP subscale scores and total score by subgroup.

Methods:

The pivotal study comprised a 5-week, open-label dose-optimization period (DOP) followed by a 2-week, randomized, cross-over double-blind treatment period (DBP). All eligible patients received d-ATS 5 mg/9 h, with weekly evaluation for dose increase and the optimal dose maintained during the DBP. Preplanned subgroup analyses of mean SKAMP total score in the DBP by optimized dose, sex, age group, ADHD type, and baseline ADHD severity were conducted. Efficacy was assessed by difference (d-ATS vs. placebo) in least-squares (LS) mean SKAMP total and subscale scores (Attention, Deportment, and Quality of Work) from a mixed-model repeated-measures (MMRM) analysis and is reported throughout as LS mean (95% confidence interval [CI]). Model-based effect sizes were calculated post hoc.

Results:

In total, 110 patients were enrolled in the DOP; 106 were randomized in the DBP. The LS mean difference in SKAMP total score of d-ATS versus placebo was −5.9 (−6.8, −5.0), with differences in subscale scores (Attention, Deportment, and Quality of Work) of −1.4 (−1.7, −1.1), −1.9 (−2.2, −1.5), and −1.3 (−1.5, −1.0), respectively. Model-based effect sizes were 0.57, 0.42, 0.43, and 0.47, respectively. Patients receiving d-ATS demonstrated improvements versus placebo in LS mean SKAMP total score at each optimized dose in both male and female patients and children and adolescents and regardless of ADHD subtype or baseline ADHD severity.

Conclusions:

Consistent efficacy of d-ATS across subgroups and all SKAMP subscale scores suggests broad utility of d-ATS in all patients, regardless of age, sex, ADHD type, or baseline ADHD severity, and broad applicability of these results to patients with varying clinical presentations of functional impairment by ADHD.

Keywords

SKAMP ADHD subscale subgroup

Introduction

Central nervous system stimulants are a first-line pharmacologic therapy for attention-deficit/hyperactivity disorder (ADHD) in children and adults (Childress and Tran, 2016; Cortese, 2020; Huss et al., 2017; Mattingly et al., 2017; Wolraich et al., 2001). Transdermal patch systems offer practical and pharmacokinetic advantages that may enhance clinical outcomes and adherence, including reduced dosing frequency; steady plasma concentrations; the ability to terminate or adjust treatment easily; bypass of hepatic first-pass metabolism; and increased bioavailability, allowing lower doses (Citrome et al., 2019; Correll et al., 2022; Findling and Dinh, 2014; Stevens et al., 2015). Among pediatric patients, transdermal patches have shown high adherence rates, overcoming the impediment of low treatment adherence and persistence among children, adolescents, and adults with ADHD in the United States (Correll et al., 2022; Danielson et al., 2018; Schein et al., 2022; Staley et al., 2024).

The dextroamphetamine transdermal system (d-ATS) was developed as an alternative to extended-release oral amphetamine formulations and is the first and only transdermal amphetamine patch approved by the U.S. Food and Drug Administration (FDA) for treating ADHD in adults and pediatric patients (children and adolescents) 6 years and older (Cutler et al., 2022; Noven Therapeutics, 2022; Xelstrym Prescribing Information, 2025). In a pivotal study of children and adolescents with ADHD, daily d-ATS (applied for 9 hours to alternating hips) met its primary endpoint, efficacy of d-ATS compared with placebo, as measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham scale (SKAMP) total score, and key secondary endpoints including onset and duration of effect, as measured by SKAMP total score (Cutler et al., 2022). d-ATS is the only available amphetamine-based treatment that enables prescribers to determine when to terminate treatment (if medically indicated) by removing the patch, which allows individualized patient care (Citrome et al., 2019). d-ATS is approved for application at 10 sites: left or right side of the hip, upper arm, chest, upper back, or flank (Supplementary Fig. S1) (Xelstrym Prescribing Information, 2025).

The SKAMP scale, a validated classroom-based measure, quantifies observable ADHD-related behaviors on a 7-point impairment scale (Childress et al., 2019, 2020; Murray et al., 2009; Swanson, 1992; Wigal, 2019; Wigal et al., 1998). It helps detect real-time changes in attention and deportment, domains that influence academic functioning, and is widely used to evaluate onset, offset, and duration of stimulant effects in pediatric trials (Childress et al., 2019, 2020; Murray et al., 2009; Wigal et al., 1998). The SKAMP Attention subscale (4 items) evaluates beginning assignments, sticking with tasks, attending to an activity, and making activity transitions (Wigal et al., 2009). The Deportment subscale (four items) evaluates interactions with other children or adults and remaining quiet or staying seated according to classroom rules (Wigal et al., 2009). The Quality of Work subscale rates three additional items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing (Wigal et al., 2009).

The SKAMP scale is a frequently cited, standard ADHD clinical trial endpoint and provides insights into stimulant efficacy and duration of effect in pediatric patients (Childress et al., 2015, 2019, 2020; Kollins et al., 2021; Murray et al., 2009; Robb et al., 2017; Swanson, 1992; Weiss et al., 2021; Wigal, 2019; Wigal et al., 1998). Literature suggests that examining SKAMP Attention and Deportment factors separately may clarify treatment effects on distinct functional impairments (Murray et al., 2009).

To further evaluate the efficacy of d-ATS in children and adolescents with ADHD, we report for the first time an analysis of SKAMP subscale scores and SKAMP total score by subgroups (optimized dose, sex, age group, ADHD type, and baseline ADHD severity) from the d-ATS pivotal trial data.

Methods

Patients and study design

The pivotal study was composed of a 5-week, open-label dose-optimization period (DOP) followed by a 2-week, randomized, cross-over double-blind treatment period (DBP). The study was approved by the Western Institutional Review Board and the UC Irvine Institutional Review Board and was conducted in compliance with Good Clinical Practices (GCP), ICH Guidelines of GCP, and the principles of the Declaration of Helsinki and its most recent amendments. Written parental informed consent and written or verbal subject assent for participation in the study were obtained. Additional details have been previously reported (Cutler et al., 2022). Briefly, patients were children and adolescents 6–17 years of age with a primary diagnosis of ADHD combined, hyperactive/impulsive subtype, or predominantly inattentive subtype. At screening and baseline, patients’ ADHD-RS-IV scores needed to be ≥90% of scores among the general population of children by age and sex.

All eligible patients received d-ATS 5 mg/9 h during the DOP, with weekly evaluation for possible dose increases to 10 mg/9 h, 15 mg/9 h, and 20 mg/9 h. All study doses of d-ATS are equivalent to the corresponding approved doses listed in the prescribing information (5 mg = 4.5 mg/9 h [approved]; 10 mg = 9 mg/9 h [approved]; 15 mg = 13.5 mg/9 h [approved]; 20 mg = 18 mg/9 h [approved]) (Xelstrym Prescribing Information, 2025). Once reached, the optimal dose was maintained for the DOP and used during the DBP. During the DBP, patients were randomized to receive double-blind placebo or active treatment at the optimized dose during week 6 and then crossed over to receive the other study treatment in week 7.

Study assessments

The primary endpoint for the pivotal study was SKAMP total score. This analysis focused on evaluating SKAMP subscale scores (SKAMP-Attention, SKAMP-Deportment, and SKAMP-Quality of Work). Preplanned subgroup analyses of mean SKAMP total score were conducted by optimized dose (5, 10, 15, 20 mg/9 h), sex (male, female), age group (children [6–12 years], adolescents [13–17 years]), ADHD type (combined, predominantly inattentive), and baseline ADHD severity (ADHD-RS-IV total score 0–36 [mild-to-moderate], 37–54 [severe]) (Childress et al., 2022). Analyses were performed on the full analysis set, which included all randomized patients who received at least one dose of study medication.

Statistical analysis

Least-squares (LS) mean for each treatment, LS mean differences (d-ATS vs. placebo) with 95% confidence intervals (CI), and mixed-model effect size are reported for SKAMP subscale scores (Attention, Deportment, and Quality of Work). Model-based effect sizes were calculated post hoc as the difference in LS mean score between treatment arms divided by the root square error obtained from the model (Curtin et al., 2002).

A likelihood-based mixed-effect model for repeated measures (MMRM) was used for analyses of SKAMP total score, subscales, and total score by subgroup. The MMRM utilized a Restricted Maximum Likelihood (REML) estimation and the Kenward–Roger adjustment for standard errors. In the model, the SKAMP total score for each timepoint was analyzed with sequence (two levels), period (two levels), treatment (two levels), and time (10 levels, one for each of 30 minutes prior and 1, 2, 3, 4.5, 6, 7, 9, 10, and 12 hours post dosing) as fixed effects, while the “repeated” effect of timepoint was defined for subject-within-sequence and “variance components” covariance structure. Baseline SKAMP score was not included as a covariate. Significance threshold for difference between LS means was p < 0.05.

Results

Baseline characteristics

In total, 110 patients were enrolled in the DOP, and 106 patients were randomized in the DBP (Cutler et al., 2022). Optimized doses established during the DOP and used for the DBP are shown in Table 1. Four patients did not complete the DOP (three discontinued due to treatment-emergent adverse events [irritability, appetite loss, abdominal pain] and one patient withdrew consent). Demographics and baseline characteristics have been reported previously and are summarized in Table 2 (Cutler et al., 2022).

Table 1.

Optimized d-ATS Doses From the DOP

	5 mg/9 h	10 mg/9 h	15 mg/9 h	20 mg/9 h
n (%)	7 (7)	35 (33)	42 (39)	23 (21)

DOP, dose-optimization period.

Table 2.

Demographics and Baseline Characteristics (SAF)

	Safety populationN = 110
Age, years, mean (SD)	10.5 (3.1)
6–12 years, n (%)	80 (73)
13–17 years, n (%)	30 (27)
Sex, n (%)
Male	76 (69)
Female	34 (31)
ADHD type, n (%)
Combined subtype	59 (54)
Male patients with combined subtype	40 (36)
Female patients with combined subtype	19 (17)
Children (6–12 years)	48 (44)
Adolescents (12–17 years)	11 (10)
Predominately inattentive	51 (46)
Male patients with predominantly inattentive subtype	36 (33)
Female patients with predominantly inattentive subtype	15 (14)
Children (6–12 years)	32 (29)
Adolescents (12–17 years)	19 (17)
ADHD-RS-IV total score, mean (SD)^a	38.3 (8.6)
ADHD-RS-IV total score in males	38.8 (7.9)
ADHD-RS-IV total score in females	37.1 (10.1)
Baseline ADHD severity^b, n (%)
ADHD-RS-IV total score 0–36	46 (42)
ADHD-RS-IV total score 37–54	64 (58)

SAF included all subjects who received ≥1 dose of study medication and had ≥1 postdose safety measurement.

Assessed prior to the start of the DOP.

Minimum score = 20; maximum score = 54.

ADHD-RS-IV, attention-deficit/hyperactivity disorder-rating scale-IV; SAF, safety population; SD, standard deviation; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale.

Efficacy

The difference (d-ATS vs. placebo) in LS mean SKAMP total score and differences in Attention, Deportment, and Quality of Work subscale scores are shown in Figure 1 and Table 3. The LS mean difference in SKAMP total score was −5.9 (−6.8, −5.0), with differences in subscale scores (SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work) of −1.4 (−1.7, −1.1), −1.9 (−2.2, −1.5), and −1.3 (−1.5, −1.0), respectively. Model-based effect sizes were 0.57, 0.42, 0.43, and 0.47, respectively.

FIG. 1.

Difference (d-ATS-Placebo) in LS mean SKAMP total and subscale scores. **p < 0.001 for d-ATS vs. placebo. CI, confidence interval; DBP, double-blind period; LS, least-squares; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale.

Table 3.

LS Mean (SE) SKAMP Total and Subscale Scores, Difference (d-ATS-Placebo) in LS Mean (95% CI), and Model-Based Effect Size in the DBP

Parameter	d-ATS LS mean (SE)^a(N = 106)	Placebo LS mean (SE)^a(N = 106)	Difference in LS mean(95% CI)^a	Model-based effect size^b
SKAMP Total score	12.8 (0.3)	18.7 (0.3)	−5.9 (−6.8, −5.0)**	0.57
SKAMP-Attention	2.5 (0.1)	4.0 (0.1)	−1.4 (−1.7, −1.1)**	0.42
SKAMP-Deportment	2.4 (0.1)	4.3 (0.1)	−1.9 (−2.2, −1.5)**	0.43
SKAMP-Quality of Work	5.5 (0.1)	6.8 (0.1)	−1.3 (−1.5, −1.0)**	0.47

LS means, 95% CI, and P values are from a linear mixed model that included the SKAMP total scores for each time point; sequence, period, treatment, timepoint, and the interaction between treatment and timepoint as fixed effects; and timepoint defined for subject within sequence using a variance components correlation structure as a repeated effect.

Effect sizes based on the change in SKAMP scores from baseline were calculated as the difference in LS mean score between treatment arms divided by the root square error obtained from the model and were calculated post hoc.

**p < 0.001 for d-ATS vs. placebo.

CI, confidence interval; DBP, double-blind period; LS, least-squares; SE, standard error; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale.

Patients receiving d-ATS at each optimized dose (5 mg/9 h, 10 mg/9 h, 15 mg/9 h, and 20 mg/9 h) demonstrated improvements versus placebo in LS mean SKAMP total score: −7.3 (−10.8, −3.7), −4.5 (−6.0, −3.0), −5.9 (−7.4, −4.5), −7.6 (−9.6, −5.6), respectively (Fig. 2, Table 4). Improvements in SKAMP total score versus placebo were observed across sex, age, and ADHD subtype. Both males and females experienced significant benefit (−6.3 [−7.3, −5.2], −5.0 [−6.6, −3.4], respectively). Similar improvements were seen in children aged 6–12 years or adolescents aged 13–17 years (−7.2 [−8.2, −6.2], −2.0 [−3.6, −0.4], respectively) and in patients with combined-type and inattentive-type ADHD (−8.0 [−9.2, −6.8], −3.3 [−4.6, −2.1], respectively). Benefits were also observed during the DBP regardless of baseline ADHD severity (ADHD-RS-IV score below or above 36; −4.5 [−5.9, −3.1], −6.7 [−7.9, −5.6], respectively).

FIG. 2.

LS mean (SE) SKAMP total scores and difference (d-ATS-Placebo) in LS mean (95% CI) for subgroups in the DBP. **p < 0.001 for d-ATS vs. placebo. LS means, 95% CIs and p values are from a linear mixed model that included the SKAMP total scores for each time point; sequence, period, treatment, timepoint, and the interaction between treatment and timepoint as fixed effects; and timepoint defined for subject within sequence using a variance components correlation structure as a repeated effect. CI, confidence interval; DBP, double-blind period; LS, least-squares; SE, standard error; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale.

Table 4.

LS Mean (SE) SKAMP Total Scores and Difference (d-ATS-Placebo) in LS Mean (95% CI) for Subgroups in the DBP

Parameter	d-ATS LS mean (SE)^a	Placebo LS mean (SE)^a	Difference inLS mean (95% CI)^a
Optimized dose
5 mg/9 h	12.6 (1.2)N = 7	19.9 (1.3)N = 6	−7.3 (−10.8, −3.7)**
10 mg/9 h	13.4 (0.6)N = 34	17.9 (0.6)N = 35	−4.5 (−6.0, −3.0)**
15 mg/9 h	12.5 (0.5)N = 39	18.5 (0.5)N = 39	−5.9 (−7.4, −4.5)**
20 mg/9 h	12.4 (0.7)N = 20	20.0 (0.7)N = 20	−7.6 (−9.6, −5.6)**
Sex
Male	13.6 (0.4)N = 68	19.8 (0.4)N = 69	−6.3 (−7.3, −5.2)**
Female	11.1 (0.6)N = 32	16.2 (0.6)N = 32	−5.0 (−6.6, −3.4)**
Age group
Children	14.0 (0.4)N = 72	21.2 (0.4)N = 74	−7.2 (−8.2, −6.2)**
Adolescents	9.8 (0.6)N = 28	11.9 (0.6)N = 27	−2.0 (−3.6, −0.4)*
ADHD subtype
Combined	14.4 (0.4)N = 52	22.5 (0.4)N = 54	−8.0 (−9.2, −6.8)**
Predominantly inattentive	11.0 (0.5)N = 48	14.3 (0.5)N = 47	−3.3 (−4.6, −2.1)**
Baseline ADHD severity
ADHD-RS-IV total score 0–36	10.8 (0.5)N = 42	15.3 (0.5)N = 41	−4.5 (−5.9, −3.1)**
ADHD-RS-IV total score 37–54	14.3 (0.4)N = 58	21.0 (0.4)N = 60	−6.7 (−7.9, −5.6)**

LS means, 95% CIs and P values are from a linear mixed model that included the SKAMP total scores for each time point; sequence, period, treatment, timepoint, and the interaction between treatment and timepoint as fixed effects; and timepoint defined for subject within sequence using a variance components correlation structure as a repeated effect.

*p < 0.05, **p < 0.001 for d-ATS vs. placebo.

CI, confidence interval; DBP, double-blind period; LS, least-squares; SE, standard error; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale.

Discussion

In this study, d-ATS improved ADHD symptoms and related behaviors, as reflected by SKAMP total and Attention, Deportment, and Quality of Work subscale scores in children and adolescents. Significant improvements in SKAMP total score were consistently observed for each study dose versus placebo across age and sex, ADHD subtype, and baseline severity, indicating robust treatment effects. These findings represent the first published analyses of d-ATS using SKAMP subscales and the first reporting of laboratory classroom SKAMP data in adolescents (13–17 years), extending prior work in classroom studies limited to children aged 6–12 years (Childress et al., 2020; Faraone et al., 2023; Wigal et al., 2010). These findings further contribute to the evidence base supporting d-ATS as a treatment option for children and adolescents with ADHD.

The consistent improvements in SKAMP total score across demographic and clinical subgroups highlight the importance of evaluating their clinical significance. Effect size provides important insights into the clinical meaningfulness of observed differences (Cutler et al., 2023). FDA statistical reviews of stimulants note that planned studies often use a clinically meaningful effect size threshold of ∼0.45 as a basis for power and sample size (US Center for Drug Evaluation and Research Office of Biostatistics, 2010; US Food and Drug Administration, Center for Drug Evaluation and Research, 2018). In this study, effect sizes ranged from 0.42 to 0.57, reflecting moderate clinical improvement, within the expected range for traditional stimulants and consistent with regulatory benchmarks. Although SKAMP effect sizes cannot be directly compared across studies, a wide range of effect sizes for the SKAMP total and subscale scores for amphetamine products have been reported in laboratory classroom settings: 0.23–1.94 (Faraone et al., 2023; Wigal et al., 2010).

The ADHD-RS-IV, another clinician-rated instrument, measures severity of ADHD symptoms across clinical visits and is widely used in ADHD studies (López-Villalobos et al., 2017; Wigal et al., 2010). Reported treatment effect sizes of oral lisdexamfetamine treatment on reduction in ADHD-RS-IV total and subscale scores in laboratory classroom settings have been relatively small, approximately 0.16 across groups (Wigal et al., 2010). Effect sizes of d-ATS treatment on reduction in ADHD-RS-IV total and subscale scores ranged from 0.7 to 1.2, larger than those reported for oral amphetamines (Cutler et al., 2023; Wigal et al., 2010). Differences in effect size findings for SKAMP and ADHD-RS-IV scores may reflect the distinct dimensions of treatment response captured by each scale. The SKAMP scale evaluates real-time classroom behavior over a day, highlighting the dynamic nature of attention and behavior and therefore leading to variable effect sizes. In contrast, ADHD-RS-IV scores capture clinicians’ ratings of severity of symptoms across visits. Together, these complementary measures provide a more complete and clinically meaningful picture of treatment effects.

Some of the subgroup differences in LS mean SKAMP score warrant further consideration. Patients with the combined subtype showed greater improvements than those with the predominantly inattentive subtype. This may be related to baseline symptom burden, since the combined subtype includes both inattentive and hyperactive/impulsive domains, resulting in higher initial scores and more room to improve (American Psychiatric Association, 2022; Schwerdtfeger et al., 2009). By contrast, patients with the predominantly inattentive subtype typically have fewer baseline symptoms, which can make treatment-related improvements appear smaller (American Psychiatric Association, 2022; Wu et al., 2022). A similar pattern was observed by sex: females, who are more likely to present with the predominantly inattentive subtype, showed smaller LS mean differences than males, potentially influenced by baseline profile (American Psychiatric Association, 2022; Quinn and Madhoo, 2014; Slobodin and Davidovitch, 2019). Age-related differences were also noted, with children showing greater improvement in SKAMP scores than adolescents. This may reflect developmental changes, as hyperactive symptoms are often more prominent in childhood and diminish with age, making the combined subtype less common among adolescents (Willcutt, 2012; Yegencik et al., 2025). Despite these differences across subgroups, treatment effects remained clinically meaningful across all groups.

Several limitations should be considered when interpreting these findings. The double-blind treatment period was relatively short, which limits inferences about the durability of improvements in SKAMP scores that may be seen during routine care. Furthermore, the laboratory classroom is a structured setting that does not fully replicate typical elementary or secondary school environments, which limits generalizability to typical classrooms and home or community settings. The pivotal study sample size was modest, leading to some small subgroups and reduced precision of subgroup estimates, with a corresponding risk of type II error. Nevertheless, treatment effects were strong and consistently observed across subgroups, supporting the robustness of the findings.

Conclusion

This analysis showed that d-ATS was efficacious in the treatment of ADHD in children and adolescents by improving SKAMP total score and Attention, Deportment, and Quality of Work subscale scores, suggesting broad applicability of these results to patients with varying clinical presentations of functional impairment. d-ATS was also efficacious regardless of optimized dose, sex, age group, ADHD type, or baseline ADHD severity, representing a valuable treatment option for various patients. Consistent efficacy across age groups suggests broad utility for d-ATS in children and adolescents with ADHD.

Clinical Significance

The consistent efficacy of d-ATS across demographic and clinical subgroups and across all SKAMP subscale scores suggests meaningful utility for d-ATS in all patients, regardless of age, sex, ADHD type, or baseline ADHD severity. These findings indicate that improvements in attention, deportment, and quality of work can be achieved in patients who differ in both clinical profile and dose requirement, supporting the use of d-ATS in routine practice, where heterogeneity of clinical presentations and functional impairment by ADHD are common.

Authors’ Contributions

All authors contributed equally, and all were involved in study design, data acquisition, or data analysis/interpretation and in drafting or critically revising the article. All authors reviewed the final article and gave approval for submission.

Footnotes

Acknowledgments

The authors thank Elizabeth Schoelwer, PharmD, and Anthony DiLauro, PhD, of the Spark Division of Woven Health Collective, LLC (New York, NY), for medical writing and editorial assistance, which were funded by Noven Pharmaceuticals, Inc. This article was prepared according to the International Society for Medical Publication Professionals’ Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update (DeTora et al. ).

Author Disclosure Statement

A.J.C. received grants from Akili Interactive, Allergan, Arbor, Emalex, Ironshore, KemPharm, Lumos, Neos Therapeutics, Otsuka, Pfizer, Purdue, Rhodes, Servier, Sunovion, Supernus, Takeda (Shire), and Tris Pharma; received personal fees from AbbVie, Acadia, Akili Interactive, Alfasigma, Alkermes, Attentive, Axsome, Corium, Intracellular Therapies, Ironshore, Janssen, Lundbeck, MedAvante-ProPhase, Neurocrine, Neuroscience Education Institute, Noven, Otsuka, and Sage; and had other relationship(s) with Cognitive Research (Data and Safety Monitoring Board) and Neuroscience Education Institute (employee and board member). M.Ko., M.C., S.M., M.Kh. are employees with and received nonfinancial support from Noven Pharmaceuticals.

Supplemental Material

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