KP415 Classroom Study in Children (6-12 Years of Age) With ADHD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (NCT03292952), a randomized phase 3 study. The primary outcome is Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores.

2. Clinical Question

3. Trial Design

This was a completed phase 3, multicenter, randomized, parallel-group study in children with ADHD. The registry describes it as dose-optimized, double-blind, and placebo-controlled, and records quadruple masking. The listed study interventions were KP415 oral capsule and placebo oral capsule. The arm descriptions include double-blind KP415, double-blind placebo, and open-label KP415. The registry record does not describe the sequence linking these groups or explain how the open-label group relates to the randomized primary comparison.

The double-blind KP415 description lists three SDX/d-MPH dose combinations: 28/6 mg, 42/9 mg, and 56/12 mg. Each is paired in the record with a molar equivalent d-MPH HCl amount. The placebo arm received an oral capsule. Although dose optimization is part of the study description, the method for choosing or assigning doses is not reported in the registry record. Details of randomization, allocation concealment, and the specific roles masked are also not reported.

Enrollment was 155, and the study status is completed. The primary outcome results compare Active Treatment with Placebo Treatment; the posted arm summaries list 74 participants for active treatment and 75 for placebo. The outcome timeframe is the average across all time points during the full laboratory classroom day on Day 7, which the registry also identifies as Day 28 of the overall study.

The registry record gives the study start as 2017-12-20 and primary completion as 2018-05-16. It does not report the original sample-size justification, the planned allocation ratio, interim analyses, or the protocol’s full statistical analysis plan. Those omissions limit how fully the conduct and design choices can be assessed from the registry information alone.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Open-Label Dose Optimization

Double-Blind Treatment Phase

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, measured over Average of all time points during the full laboratory classroom day, which occurred on Day 7 (Day 28 of the overall study) of the Treatment Phase.

The primary endpoint was change from baseline in the Swanson, Kotkin, Agler, M-Flynn, and Pelham combined score, or SKAMP-C. The registry describes SKAMP as a validated rating of subjective impairment in classroom behavior among children with ADHD. Trained study personnel rated 13 items covering attention, deportment, quality of work, and compliance. Each item uses a seven-point scale from 0, normal, to 6, maximal impairment; the summed combined score ranges from 0-78. Higher scores mean greater impairment.

The endpoint is a continuous measure, so the reported outcome is a least-squares mean change rather than a count or proportion. The registry specifies that the endpoint is averaged across all time points during the full laboratory classroom day. That day occurred on Day 7, identified as Day 28 of the overall study’s Treatment Phase. The registry record does not give further detail about the timing of baseline measurement or the individual classroom assessment time points.

A classroom rating is used to quantify observed behavior in a structured setting, rather than relying only on an overall impression. The direction of the scale matters when interpreting a change: a lower score represents less rated impairment, while a higher score represents more. The outcome describes the measured score in this laboratory classroom context; it does not by itself establish how the result applies to other settings or to every child with ADHD.

7. Results Posted in the Registry

• Active Treatment: mean -4.87 versus 0.54 on control; difference -5.41 (95% CI -7.24 to -3.57), standardized effect d = -0.95; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Double-Blind KP415: mean 25.82 versus 2.25 on control; difference 23.57 (95% CI 14.56 to 32.58), standardized effect d = 0.84; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Double-Blind KP415 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry posts one secondary outcome: change from baseline in PERMP-A, the number of problems attempted. The posted summaries show a positive change for the double-blind KP415 group relative to placebo, and the recalculated comparison is positive. This pattern is directionally distinct in its scale from the primary endpoint: higher PERMP-A refers to more problems attempted, whereas lower SKAMP-C reflects less rated impairment.

The secondary measure complements the primary classroom behavior rating by capturing a performance quantity rather than a rating of impairment. Agreement in broad classroom context does not make the outcomes equivalent. They assess different constructs and may respond differently to study conditions. The registry record does not report a sponsor analysis for PERMP-A, so the secondary comparison available is the unadjusted recalculation from the posted summaries.

Unadjusted secondary results carry less inferential weight when the analysis plan and multiplicity handling are not reported. Testing multiple outcomes can increase the chance of a low p-value arising among the set of tests. The registry lists two outcome measures, but does not state whether a hierarchy or multiplicity adjustment was prespecified. The secondary result should therefore be considered alongside the primary outcome, not as an independent confirmation that resolves limitations in the primary analysis.

The overall pattern is that the posted primary and secondary group comparisons point in favorable directions for their respective scale interpretations. That pattern is descriptive. Without reported prespecification, adjustment procedures, and sponsor analysis details for the secondary outcome, it does not establish the strength of confirmatory evidence across endpoints.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a score on a scale, and the registry reports least-squares mean changes. A mean summarizes the central tendency of the group’s observed or modeled changes. It does not describe every participant’s individual score, and it can conceal variation in responses. The score’s direction is important: higher SKAMP-C values indicate greater impairment. Thus, a negative change represents a reduction in the score relative to baseline, while the between-group contrast describes how the estimated changes compare.

What does a mean difference represent?

The recalculated primary mean difference is -5.406 score points, with active treatment subtracted from placebo in the comparison definition. The group change estimates are -4.87 and 0.536. Subtracting the placebo estimate from the active-treatment estimate gives the posted recalculated contrast; no adjustment for other variables is included in that simple comparison. The contrast is expressed in the original score units, which helps relate it to the scale, but the registry record does not report a threshold for a clinically important difference.

A standardized effect size can describe a difference relative to variation, but the reported standardized estimates are not needed to understand the raw score contrast. Because the standard deviations are not directly posted, the recalculation uses approximate standard deviations derived from the reported standard errors and group sizes. That approximation is a feature of the recalculated comparison, not a description of the sponsor’s ANCOVA model. It should not be confused with a directly reported trial estimate.

What does ANCOVA do?

The registry lists ANCOVA for the sponsor’s primary superiority analysis. In general, analysis of covariance compares groups while adjusting for selected covariates. Adjustment can account for measured baseline or design variables and may improve precision when the model is appropriate. The registry record does not identify the covariates, model specification, handling of missing values, or analysis population. Those details cannot be inferred from the method label alone.

The sponsor analysis reports p < 0.001 for superiority. A p-value is calculated under a statistical model and a null hypothesis, and describes how incompatible the data are with that null under the model’s assumptions. It is not a measure of the probability that the result occurred by chance, and it does not measure effect size. The unadjusted recalculation also reports p < 0.001, but it uses a different analytical approach and should be interpreted as a separate summary-based calculation.

Why can over-dispersion matter?

General statistical explanation: over-dispersion occurs when outcome variability exceeds what a model assumes. If a model understates variation, uncertainty can be understated and tests can appear more decisive than warranted. The primary endpoint is a continuous score, and the registry does not report an over-dispersion assessment or a model-based variance diagnostic. The concept is relevant when evaluating model assumptions, but there is no registry basis for concluding that over-dispersion did or did not affect this analysis.

Standard errors describe uncertainty in an estimated mean under the calculation used. The primary arm summaries report standard errors of 0.62 for active treatment and 0.7 for placebo. These are not standard deviations of individual participant scores. A standard error generally becomes smaller when an estimate is more precise, but its interpretation depends on the estimator, sample, and analysis method. The registry does not give the underlying individual observations needed to independently assess the distribution of scores.

The reported confidence interval for the recalculated mean difference expresses a range of values compatible with the summary-based estimate under the interval’s assumptions. Its bounds are -7.239 and -3.573. The reported ANCOVA result does not include an estimate or interval in the registry information, so the recalculated interval should not be attributed to the sponsor’s adjusted model. The confidence level for the recalculated interval is not stated in the registry record.

How should the secondary result be treated?

The secondary continuous outcome, PERMP-A, is also reported as a least-squares mean change. Its recalculated mean difference is 23.57, with a confidence interval from 14.56 to 32.58, and its unadjusted p-value is < 0.001. The registry does not list a sponsor-reported analysis for this endpoint. The primary and secondary results should not be treated as if they necessarily share the same analysis model or inferential status.

Multiplicity arises when more than one outcome or comparison is tested. In general, testing several hypotheses without an appropriate plan can increase the chance of at least one apparently strong result even when all null hypotheses are true. The registry lists two outcome measures and one posted secondary outcome, but does not report a multiplicity adjustment or a hierarchy for interpretation. The secondary p-value is identified as unadjusted in the recalculation and should be viewed as exploratory evidence unless a prespecified analysis plan establishes otherwise.

Statistical significance and practical importance are different questions. A small p-value does not tell readers whether a score difference matters to children, families, or classroom functioning. The registry description explains the scale but does not report a meaningful-change threshold or a patient-level interpretation. The study results can describe the measured group contrast; they cannot supply that missing clinical benchmark.

11. Confidence Intervals and Precision

The recalculated primary mean difference is -5.406 score points, with a confidence interval from -7.239 to -3.573. The interval gives a range of estimates compatible with the summary-based calculation under its assumptions. Because both listed bounds are below zero, the interval is consistent with a negative active-minus-placebo contrast. The registry does not report the confidence level for this recalculated interval, and it should not be read as the interval from the sponsor’s ANCOVA.

Precision concerns how narrowly an estimate is determined, not whether it is important. The primary arm summaries include standard errors of 0.62 for active treatment and 0.7 for placebo. Standard errors describe uncertainty in the estimated means; they do not show the spread of individual participant scores. The posted means and standard errors therefore provide only a partial picture of outcome variability and individual response patterns.

The secondary recalculated mean difference is 23.57, with a confidence interval from 14.56 to 32.58. Its bounds are positive. That interval also belongs to the unadjusted summary-based calculation, not a sponsor-reported secondary model; no sponsor analysis is listed for the secondary endpoint. The registry record does not report confidence levels for the recalculated intervals.

The intervals do not account for every source of uncertainty in study interpretation. Unreported analysis details, missing-data handling, the analysis population, and multiplicity procedures may affect how the results should be understood. Nor does a confidence interval describe the range of individual participant outcomes. It quantifies uncertainty around a group-level estimate under specified statistical assumptions.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total event counts. They are illustrations based on the observed effect, not the trial’s original design justification. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

For each effect-size scenario, the 80% power column gives the estimated number of participants per arm for a design with an 80% chance of detecting that assumed effect at the stated significance level, if the assumptions hold. The 90% power column gives the corresponding per-arm planning estimate for a design with a 90% chance. These are design calculations, not descriptions of the study’s actual power or evidence that the trial did or did not have adequate power.

The planning estimates are shown for detecting 100%, 75%, and 50% of the observed effect. As the target effect becomes smaller, more participants are needed per arm to distinguish it from random variation under the same planning assumptions. For example, planning for 50% of the observed primary effect gives estimates of 71 participants per arm for 80% power and 94 for 90% power. These estimates are sensitive to the observed effect used as their starting point; if that estimate is optimistic or unstable, the resulting planning illustration may also be optimistic or unstable.

This is not observed power. Observed power is not a useful substitute for interpreting the estimate and its uncertainty after a study is complete. The planning figures are best read as conditional illustrations for future design choices, not as a verdict on the trial’s results.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -5.406; pooled standard deviation σ = 5.712.
2. n = 2 × (1.96 + 0.842)² × 5.712² / -5.406² = 17.5, rounded up to 18 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -5.406                      # observed difference in means
sigma <- 5.71192141564495                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3292952)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 18 (80% power), 24 (90% power)
 75% of observed effect: n per arm = 32 (80% power), 42 (90% power)
 50% of observed effect: n per arm = 71 (80% power), 94 (90% power)
power.t.test: 18.5 
Simulated power at n = 18 per arm: 0.791 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports that the sponsor analyzed the primary comparison with ANCOVA and found p < 0.001 for superiority. It does not provide the ANCOVA estimate, confidence interval, covariates, or further model details. The sponsor’s analysis is therefore the reported adjusted analysis, while the recalculated mean difference and interval are unadjusted calculations from the posted group summaries.

The recalculated primary contrast is -5.406 score points, with a confidence interval from -7.239 to -3.573, and its unadjusted p-value is < 0.001. These results provide a summary-based comparison that is directionally consistent with the reported group changes. However, similarity in the thresholded p-values does not mean the procedures are interchangeable: the ANCOVA may account for covariates, whereas the recalculation does not.

The registry information does not identify a discrepancy between the reported and recalculated primary results. Even so, the recalculation is not a reconstruction of the ANCOVA, and it cannot validate unreported modeling choices. The sponsor’s own ANCOVA is the trial’s reported inferential analysis; the recalculation is supplementary context based on the available summary statistics.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity concerns arise when several outcomes, comparisons, or analyses are examined. In general, the more hypotheses tested, the greater the possibility of observing a statistically notable result by chance somewhere among them if no adjustment or prespecified hierarchy is used. The registry lists two outcome measures and one posted secondary outcome. It does not report a multiplicity adjustment, a testing hierarchy, or whether any outcomes were designated for confirmatory interpretation in a protocol or analysis plan.

The primary result has a sponsor-reported ANCOVA superiority test with p < 0.001. The secondary comparison has an unadjusted recalculated p-value of < 0.001, and no sponsor-reported secondary analysis is listed. These p-values should not automatically be read as though they arose from a single prespecified testing family. The registry record does not explain how the secondary result was incorporated into the trial’s inferential plan.

Missing-data methods are also not reported in the registry record. The posted outcome summaries give group sizes, but do not explain whether all randomized participants contributed endpoint data, how missing values were handled, or whether any imputation or sensitivity analyses were used. The record does not identify the primary analysis population, such as whether it was based on all randomized participants or another defined set.

Further analysis details are not reported, including the ANCOVA covariates, model specification, handling of protocol deviations, and interim analyses. Their absence does not establish that such procedures were not conducted; it means they cannot be evaluated from the registry record. These omissions constrain assessment of the robustness of the reported estimates and the relationship between the posted outcome summaries and the sponsor’s adjusted analysis.

In general, prespecified analysis choices help distinguish confirmatory tests from exploratory ones and reduce the risk of selective emphasis. Without the trial’s full statistical plan and missing-data reporting, the posted results remain interpretable as reported estimates and tests, but the full inferential context is incomplete.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 2% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event summaries report zero affected participants in each listed group: Open-Label KP415, Double-Blind KP415, and Double-Blind Placebo. The record lists 155 at risk in the open-label group, 74 in the double-blind KP415 group, and 76 in the double-blind placebo group. It also reports zero deaths in each group. No serious adverse event terms are listed.

These figures describe the registry’s reported counts; they do not establish that no adverse experiences occurred. The same record lists other adverse events affecting 104 participants in the open-label group, 13 in the double-blind KP415 group, and 6 in the double-blind placebo group. Those are recorded separately from serious adverse events.

The group denominators differ from some outcome-summary group sizes, and the registry does not explain the safety observation periods or the relationship between the open-label and double-blind groups. Counts should not be treated as directly comparable rates without that context. The safety summaries are descriptive and do not, by themselves, establish comparative risk or causation.

17. What the Result Does, and Does Not, Mean

The posted primary result describes a difference between group-level changes in a classroom behavior rating during a specified laboratory classroom day. The recalculated estimate is in the direction of a lower SKAMP-C score for active treatment relative to placebo, and the sponsor reports p < 0.001 for its ANCOVA superiority analysis. These are statistical findings about the measured endpoint and study conditions.

The result does not mean that every child’s score changed by the group average, or that participants had identical experiences. Group means and standard errors do not show the distribution of individual changes. The registry does not provide individual-level data, responder counts, or a threshold for interpreting the score difference as clinically important. Statistical evidence against a null difference is not, by itself, a judgment about practical or clinical importance.

The endpoint is a rating of classroom behavior in a laboratory classroom setting, and the secondary outcome counts problems attempted. Neither measure alone establishes outcomes in other environments or over a different timeframe. The primary assessment occurred during the full laboratory classroom day on Day 7, identified as Day 28 of the overall study. The registry record does not report longer-term outcome results in the information.

Interpretation is further bounded by missing reporting on the analysis population, missing-data handling, ANCOVA details, and multiplicity procedures. These gaps do not invalidate the posted results, but they prevent a complete assessment of how robustly the analyses address those issues. The secondary result is unadjusted in the recalculation and should not be treated as equivalent in status to the sponsor-reported primary analysis.

The data therefore support a precise description of the reported group comparison within the trial’s stated setting and timeframe. They do not warrant conclusions about individual outcomes, unmeasured settings, the clinical importance of a score change, or effects beyond what the registry record reports.

18. Why This Trial Matters Statistically

This trial illustrates why the estimand and scale direction matter when reading clinical results. The primary outcome is a summed rating of classroom impairment, with higher values indicating greater impairment. A negative active-minus-placebo contrast consequently points in the lower-score direction. In a different endpoint, such as problems attempted, a positive contrast has a different scale interpretation. Reading the sign without knowing what higher scores mean can reverse the substantive interpretation.

It also illustrates the distinction between an adjusted sponsor analysis and a recalculation from summary statistics. The registry reports ANCOVA for the primary comparison, but the recalculated mean difference uses only posted group summaries. Both report p < 0.001, yet they do not answer the question through identical models. Reporting the adjusted estimate and its uncertainty would allow readers to assess the sponsor analysis more directly.

The secondary PERMP-A outcome adds a complementary measure, but multiple outcomes raise questions about prespecification and multiplicity. The registry lists two outcome measures without describing a testing hierarchy or adjustment. That matters because a set of unadjusted tests does not have the same interpretation as a single prespecified primary test.

Finally, planning estimates based on the observed effect are not evidence of achieved power. They can illustrate how the required participants per arm changes when planning for smaller effects, while remaining dependent on explicit assumptions. Keeping design illustrations separate from observed inference helps avoid a common misreading of sample-size calculations.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves several design details unclear. Although the study is described as dose-optimized and lists multiple KP415 dose combinations, the procedure for selecting or assigning doses is not reported. The relationship between the open-label KP415 group and the double-blind randomized comparison is also not described. The record identifies quadruple masking but does not explain which roles were masked.

For the primary analysis, the registry reports ANCOVA and a p-value but not the adjusted effect estimate, its interval, included covariates, or model specification. The recalculated comparison uses posted summary statistics and approximate standard deviations; it is not a substitute for individual-level analysis or the sponsor’s adjusted model. The original sample-size justification and trial-specific assumptions are not reported.

The registry record does not report how missing endpoint data were handled, which participants were included in the analysis population, or whether sensitivity analyses were performed. It also does not provide a multiplicity plan for the listed outcomes. These omissions make it difficult to evaluate the full statistical robustness of the reported results.

Safety summaries list different denominators for the placebo group than the primary outcome summary, and the record does not explain observation periods or group transitions. The counts are therefore best read as reported rather than as directly comparable rates. The primary endpoint is confined to a laboratory classroom day, and no registry detail establishes how well it represents outcomes in other settings or over longer periods.

The registry does not state a clinically important threshold for SKAMP-C or provide individual-level response distributions. Consequently, the group estimate and its interval cannot by themselves determine the practical meaning of the score difference for individuals.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD — NCT03292952.
• Registry record last updated 2021-06-30; status last verified 2021-03.
• Results first posted 2021-06-30.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT03292952 is a completed phase 3 randomized, parallel, placebo-controlled study of KP415 in children with ADHD. The registry describes double-blind design and quadruple masking and lists an open-label KP415 group as well as double-blind KP415 and placebo groups.

The primary outcome was change from baseline in SKAMP-C during the full laboratory classroom day. The registry reports a sponsor ANCOVA superiority result with p < 0.001. The recalculated unadjusted mean difference is -5.406 score points, with a confidence interval from -7.239 to -3.573. One secondary outcome, PERMP-A, is posted; the registry does not list a sponsor analysis for it.

Important analysis details, including missing-data handling, analysis populations, multiplicity procedures, and the ANCOVA model, are not reported in the registry record. The results describe the posted group comparisons in the stated classroom setting and timeframe.