Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults (NCT03342963), a randomized phase 1 study. The primary outcome is Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1.

2. Clinical Question

The trial’s title also describes an investigation of food effects on pharmacokinetics in Cohort 2. In that cohort, ASC-01 was administered under fasting or fed conditions. The primary result discussed in the registry record, however, is peak plasma concentration of aripiprazole in Cohort 1. It is not a reported result for the Cohort 2 food comparison.

The formulation comparison asks whether exposure to aripiprazole, as reflected by its peak plasma concentration, differs between the combination tablet and concomitant separate medicines. This is a pharmacokinetic question, not a comparison of clinical symptoms or long-term outcomes. The registry record identifies the study as Phase 1 and lists healthy male adults as the condition. It does not report a clinical efficacy endpoint.

The posted means are 18.8 ng/mL for ASC-01 and 16.9 ng/mL for concomitant aripiprazole and sertraline. The displayed comparison is a mean difference of -1.9 ng/mL for concomitant administration relative to ASC-01. Whether those results satisfy a prespecified bioequivalence criterion cannot be established from the posted information: equivalence margins and a corresponding formal analysis are not reported in the registry record.

3. Trial Design

The registry record describes NCT03342963 as a randomized, open-label, single-center, two-treatment, two-period crossover trial. It is listed as Phase 1 and completed, with enrollment of 74. Masking is listed as none. The trial title and arm descriptions cover two cohorts, with different questions: a formulation comparison in Cohort 1 and a food-condition comparison in Cohort 2.

In Cohort 1, participants received ASC-01 in one period and aripiprazole plus sertraline concomitantly in the other. The order was reversed for the other treatment sequence. Both administrations were specified after 10 or more hours of fasting. In Cohort 2, ASC-01 was administered in both periods, once after fasting and once 30 minutes after the start of breakfast; the order of those conditions was reversed for the other sequence.

A crossover design uses each participant’s experience under one treatment condition alongside their experience under another condition. This can help account for stable differences between participants when the analysis appropriately uses the paired observations. General statistical context: a crossover comparison also depends on design and analysis details such as the washout interval, period effects, sequence effects, and how within-participant measurements are modeled. Those details are not reported in the registry record, so the adequacy of the washout or the analysis of possible period and sequence effects cannot be assessed from this record.

The primary outcome is peak plasma aripiprazole concentration in Cohort 1. The Pharmacokinetic Analysis Set is defined as subjects who received investigational medicinal product and for whom plasma drug concentration data were obtained. The posted arm summaries list 40 for ASC-01 and 39 for concomitant aripiprazole and sertraline. Adverse-event groups have separate denominators, and should not be assumed to represent the same analysis population. The registry record does not explain the relationship among these denominators.

The arm descriptions specify treatments and fasting conditions, but do not report the randomization procedure, allocation concealment, washout length, or reasons for any difference between the listed population counts. The trial’s own sample-size justification and original design assumptions are also not reported in the registry record.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained.

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.

Population: Safety Set: subjects who received investigational medicinal product (IMP) at least once.

6. Primary Endpoint

The registry lists the primary outcome as Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1, measured over Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing.

The primary endpoint is peak plasma concentration (Cmax) of aripiprazole in Cohort 1, measured in ng/mL. Cmax is the highest measured concentration of a drug in plasma over the scheduled sampling period. The listed timeframe includes baseline and measurements at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours after dosing.

Peak concentration is one measure of drug exposure. It is useful in a pharmacokinetic comparison because it describes the observed maximum concentration after administration, while other pharmacokinetic measures can describe exposure over time or the timing of that peak. The registry record lists four outcome measures, but the remaining measure details and results are not reported in the record. The posted primary outcome is specifically about aripiprazole; it should not be read as a peak-concentration result for sertraline.

The endpoint is summarized as a mean with standard deviation. The posted mean is 18.8 ng/mL for ASC-01, with standard deviation 5.33, and 16.9 ng/mL for concomitant aripiprazole and sertraline, with standard deviation 4.38. A mean describes the center of the observed concentration values, while the standard deviation describes their spread around that mean. These summaries do not by themselves describe every participant’s concentration profile or the paired within-person differences that matter in a crossover design.

General statistical context: bioequivalence is usually assessed against prespecified acceptable limits for a treatment comparison, using an analysis designed for that purpose. The registry record does not report the limits or the formal bioequivalence decision rule. Therefore the endpoint summaries alone cannot establish whether the trial met a bioequivalence criterion.

7. Results Posted in the Registry

• Aripiprazole/Sertraline Concomitant: mean 16.90 versus 18.80 on control; difference -1.90 (95% CI -4.05 to 0.25), standardized effect d = -0.39; z-test p = 0.083.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous measurement: peak plasma aripiprazole concentration in ng/mL. The registry record summarizes it using an arithmetic mean and standard deviation for each listed treatment. The mean provides a measure of the center of the observed values. The standard deviation describes how dispersed values are around that center. It is not the same as the uncertainty around the estimated mean or the estimated treatment difference.

What does the mean difference describe?

The displayed comparison reports a mean difference of -1.9 ng/mL for concomitant aripiprazole and sertraline relative to ASC-01. In general, a difference is expressed in the original measurement unit, so its scale is directly interpretable as a concentration difference. The sign depends on the comparison direction: a negative value means the mean for the named comparison treatment is lower than the mean for the reference treatment, as reflected in the posted means. The difference is a summary, not a description of every participant’s response.

Although the comparison is reported as a mean difference, the record does not describe the statistical model or confirm how the crossover structure was handled. In a crossover study, measurements from the same participant are related rather than independent. General statistical context: paired analyses use that relationship, often improving precision compared with treating observations as unrelated, but only if the relevant paired data and model assumptions are appropriate. The posted arm-level means and standard deviations alone do not reveal the within-participant correlation or the distribution of paired differences.

What does the p-value tell the reader?

The reported p-value is unadjusted and equals 0.083. In general, a p-value is calculated under a null hypothesis and model assumptions; it measures how unusual data at least as inconsistent with that null would be if the null model were correct. It is not the probability that the null hypothesis is true, nor is it the probability that the observed treatment difference is due to chance. A p-value also does not establish equivalence. Interpretation depends on the planned question, study design, endpoint, and analysis.

The record does not report the prespecified hypothesis test, the confidence level for the accompanying interval, the model specification, or whether the displayed p-value came from a crossover model or a different calculation. It lists zero posted analyses. The comparison’s p-value is therefore described as posted, not as an independently verified analysis. The registry record does not report adjustment for multiple outcomes or comparisons.

Why does an interval matter?

The reported interval for the mean difference ranges from -4.049 to 0.249. General statistical context: a confidence interval expresses uncertainty around an estimated quantity under a statistical procedure and its assumptions. Wider intervals represent less precision than narrower intervals on the same scale. An interval that includes zero is compatible with no mean difference under the interval’s construction, but it can also include nonzero differences. It does not, by itself, establish that the treatments are equivalent or that any values in the interval are clinically unimportant.

The record does not name the confidence level or provide the exact method used to construct the interval. The interval should therefore be read as a reported uncertainty range, without assigning it a conventional confidence percentage that is not specified in the registry record. Its endpoints are not a guarantee that the true difference lies within them.

How does crossover design affect interpretation?

General statistical context: crossover studies compare treatments within participants, which can reduce the influence of stable person-to-person differences. The design also requires attention to period, sequence, and possible carryover effects. Appropriate analysis generally uses the paired structure and the randomized treatment sequences. A washout period can be important when effects may persist, but the washout interval is not reported in the registry record. The record also does not state how period, sequence, or carryover were evaluated, or what model was used for the primary outcome.

The outcome’s analysis population is defined as participants who received investigational medicinal product and had plasma drug concentration data. The posted outcome summaries list 40 under ASC-01 and 39 under concomitant treatment. It is not clear from the record why these treatment-specific counts differ, whether all participants contributed to both periods, or how missing concentration measurements were handled. These issues matter because incomplete pairs can affect which participants contribute to a crossover comparison.

What does bioequivalence require?

General statistical context: a conventional difference test asks whether the data provide evidence against a null hypothesis of no difference. Bioequivalence instead asks whether the treatment difference is sufficiently constrained within predefined acceptable limits. That requires limits chosen before interpreting the outcome and an analysis matched to the bioequivalence question. The registry record does not report equivalence limits, a prespecified decision rule, a treatment ratio, or the formal bioequivalence analysis. The unadjusted p-value and mean difference should not be substituted for those missing elements.

The record supplies a planning illustration based on the observed effect, under a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. This is separate from the trial’s own sample-size justification, which is not reported. Such planning calculations depend on the estimated effect and assumptions; they do not show that the original study was designed around these values. The illustration is not observed power. More detail about how the reported effect and variability were translated into the planning estimates is not reported in the registry record.

10. Confidence Intervals and Precision

The primary comparison’s reported interval extends from -4.049 to 0.249 ng/mL, around a mean difference of -1.9 ng/mL for concomitant aripiprazole and sertraline relative to ASC-01. The interval includes zero and spans both negative and positive values. It therefore communicates uncertainty about the direction and size of the mean difference, rather than a precise estimate concentrated on one side of zero.

In general, an interval is more informative than a point estimate alone because it displays a range of values compatible with the data and the interval procedure. The width reflects both the variability in the observations and the amount of information available, as well as the statistical method used. The posted standard deviations are 5.33 for ASC-01 and 4.38 for concomitant treatment. Those values describe dispersion in the outcome, not the precision of the comparison by themselves.

The confidence level and construction method for the reported interval are not reported in the registry record. Also not reported are the within-participant correlation, paired-difference distribution, or the model used to account for the crossover. These are relevant to judging the precision of a crossover comparison. Consequently, the interval can be described as posted, but its assumptions and reproducibility cannot be fully evaluated from the registry record.

For a bioequivalence question, precision must be considered against predefined acceptable bounds. The interval crossing zero is not enough to determine equivalence, because the record does not give the equivalence limits or the formal analysis. A narrow interval can still fail an equivalence criterion if it falls outside the specified limits, while a broad interval may leave substantial uncertainty. Neither the bounds nor a formal decision are reported.

The reported point estimate and interval are specific to peak plasma aripiprazole concentration in Cohort 1. They do not establish precision for other pharmacokinetic measures, sertraline concentrations, food effects, or clinical outcomes.

11. 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 sample-size display gives planning illustrations in participants per arm, not total events. The calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They consider detecting the stated fraction of the observed effect. The original trial’s own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the illustration estimates would be needed for an 80% chance of detecting the specified effect under its assumptions. The 90% power column gives the corresponding planning number for a 90% chance. These are prospective planning concepts, not observed properties of the completed trial. The displayed illustrations are not observed power.

The rows use 100%, 75%, and 50% of the observed effect. For planning at 100% of the observed effect, the display gives 104 participants per arm for 80% power and 139 participants per arm for 90% power. For planning at 75% of the observed effect, the figures are 185 and 247 participants per arm, respectively. For planning at 50% of the observed effect, the figures are 415 and 556 participants per arm, respectively.

Smaller effects are harder to distinguish from background variability, so the illustration requires more participants per arm as the effect being targeted becomes smaller. A higher power target also requires more participants per arm under the same assumptions. Because these estimates are based on the observed effect and a simplified normal approximation, they are illustrations rather than recommendations or evidence about the trial’s original planning. The registry record does not report a sample-size calculation used to design this trial.

12. 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 = -1.900; pooled standard deviation σ = 4.884.
2. n = 2 × (1.96 + 0.842)² × 4.884² / -1.900² = 103.7, rounded up to 104 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 <- -1.9                      # observed difference in means
sigma <- 4.88431667182313                     # 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(3342963)
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 = 104 (80% power), 139 (90% power)
 75% of observed effect: n per arm = 185 (80% power), 247 (90% power)
 50% of observed effect: n per arm = 415 (80% power), 556 (90% power)
power.t.test: 104.7 
Simulated power at n = 104 per arm: 0.800 (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.

13. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures and zero posted analyses. The primary outcome described in the record is peak plasma aripiprazole concentration in Cohort 1. The other outcome measures, their detailed results, and any analysis of Cohort 2’s food comparison are not reported in the registry record. The record does not explain whether the four outcomes correspond to separate endpoints, multiple pharmacokinetic measures, or a hierarchy of planned questions.

Multiplicity arises when several outcomes, comparisons, or analyses are considered. In general, testing many questions can increase the chance of at least one result appearing notable by chance. Statistical plans may address this through a hierarchy, adjustment, or another prespecified strategy. Whether such a strategy was used is not reported in the registry record. The posted p-value is identified as unadjusted, and no multiplicity procedure is described. The number of prespecified comparisons and any rules for interpreting them are also not reported.

The primary outcome population is defined as subjects who received investigational medicinal product and for whom plasma drug concentration data were obtained. This is a pharmacokinetic analysis population, not a complete description of all randomized participants. The treatment summaries list 40 for ASC-01 and 39 for concomitant administration. The registry record does not report a participant flow, reasons for exclusions, the number with complete paired measurements, or how missing concentration values were handled.

General statistical context: missing measurements can matter differently in a crossover study depending on whether one or both treatment periods are observed and on why data are missing. An analysis may require paired observations, but the registry record does not state whether that was required or how incomplete pairs were used. It also does not report imputation methods, sensitivity analyses, or assumptions about missingness.

The treatment groups in the adverse-event record have their own at-risk denominators. They should be read as safety summaries, not assumed to be identical to the primary pharmacokinetic analysis set. The registry record does not give enough participant-flow detail to reconcile the different denominators or identify a single population applicable to every outcome.

14. 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 1% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event summaries report zero affected participants in each listed group: Cohort 1 ASC-01, Cohort 1 concomitant aripiprazole and sertraline, Cohort 2 ASC-01 under fasted conditions, and Cohort 2 ASC-01 under fed conditions. The corresponding numbers at risk are 52, 52, 20, and 20. No serious adverse event terms are listed.

These counts describe what is recorded for the specified groups and observation period; they do not establish that serious events are impossible or that the treatments have no safety risks. General statistical context: when no events are observed in a group, the estimate remains uncertain, especially when the group is limited in size or follow-up is short. The registry record does not report the duration of safety follow-up in the adverse-event results, so the extent of observation cannot be characterized from these counts alone.

The record separately reports other adverse events affecting 44 participants in Cohort 1 ASC-01, 43 in Cohort 1 concomitant treatment, 12 in Cohort 2 fasted ASC-01, and 14 in Cohort 2 fed ASC-01. These are not serious-event counts. Adverse-event summaries should be read alongside their group definitions and denominators, and should not be combined across cohorts or treatment conditions. They are descriptive counts, not a comparative statistical analysis.

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

The posted result describes peak plasma aripiprazole concentration after a single dose in healthy male adults. In Cohort 1, the mean was 18.8 ng/mL after ASC-01 and 16.9 ng/mL after concomitant aripiprazole and sertraline. The displayed mean difference for concomitant treatment relative to ASC-01 is -1.9 ng/mL. The unadjusted p-value is 0.083, and the reported interval includes zero.

These results do not establish that the two regimens are identical. A non-small p-value is not evidence that any difference is exactly zero. Nor do the results, as posted, establish bioequivalence: the registry record does not report predefined equivalence limits or the formal analysis needed to judge the result against such limits. The interval describes uncertainty around the reported difference, but its confidence level and method are not reported.

The result is limited to the primary endpoint and population described. It does not report a conclusion about sertraline exposure, the Cohort 2 food effect, repeated dosing, long-term outcomes, effectiveness, or people outside the stated healthy male adult population. The record lists four outcome measures, but detailed results for the other measures are not reported.

The design is a randomized crossover, which can support within-participant comparisons, but the registry record does not explain the model used or how period, sequence, washout, and incomplete observations were addressed. The arm-level means and standard deviations do not reveal the individual paired differences. These limitations matter when judging how fully the posted summary represents the intended crossover comparison.

The safety record reports no serious adverse events in the listed groups, while other adverse events are recorded. Zero observed serious events in these groups should not be interpreted as proof of zero risk. The results are descriptive observations from this study and are not medical advice.

16. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between comparing average outcomes and establishing equivalence. The posted primary result is a difference in mean peak plasma concentration, with an unadjusted p-value and an interval. Those quantities address uncertainty about a mean difference under a particular analysis. A bioequivalence question instead requires predefined acceptable limits and an analysis that evaluates whether uncertainty lies within those limits. The registry record does not report those limits or a formal decision rule.

The crossover structure also makes the analysis more than a comparison of two independent group averages. Each participant may contribute measurements under both treatment conditions, so the relationship between those measurements can affect the precision of the estimated treatment effect. The posted means and standard deviations offer useful descriptive information, but do not provide the paired data or model details needed to assess that structure. The washout, period and sequence analyses, and handling of incomplete observations are not reported.

The sample-size illustration offers a further statistical lesson: planning depends on the size of the effect a study aims to detect and the desired probability of detection. Its estimates increase for smaller target effects and for the higher power target. These are planning illustrations based on the observed effect, not evidence that the study’s original design had a particular power or justification. The original design assumptions are not reported in the registry record.

Finally, distinct populations appear in the pharmacokinetic and safety summaries. The primary outcome population is defined by drug receipt and available plasma concentration data, while the adverse-event groups have separate at-risk counts. Interpreting each result in its own population, without treating the denominators as interchangeable, is important for transparent clinical-trial reporting.

17. 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 gives a limited account of the statistical analysis. It does not report the model used for the primary comparison, the confidence level or construction method for the reported interval, or how the crossover design was incorporated. It also does not provide the within-participant correlation or paired-difference summaries. Therefore, the primary comparison cannot be fully reproduced or evaluated as a crossover analysis from the posted summaries alone.

Several design and data-handling details are not reported in the registry record: the washout duration, the randomization procedure, treatment allocation concealment, handling of incomplete treatment periods, missing-data methods, and any evaluation of period, sequence, or carryover effects. These details could affect interpretation of a crossover pharmacokinetic comparison.

The record does not provide the prespecified bioequivalence margins, the formal decision rule, or the trial’s own sample-size justification. It also does not describe a multiplicity strategy despite listing four outcome measures. No analyses are listed, and detailed results for other pharmacokinetic outcomes and the Cohort 2 food comparison are not reported.

The primary summaries are based on the stated Pharmacokinetic Analysis Set, with treatment-specific counts of 40 and 39. The record does not provide participant flow or explain the relationship between these counts and the adverse-event at-risk denominators of 52 and 52 in Cohort 1 and 20 and 20 in Cohort 2. These counts refer to different reported summaries and should not be treated as interchangeable.

Finally, the trial is described as a single-center Phase 1 study in healthy male adults, and the primary endpoint is a single-dose pharmacokinetic measure. The posted result therefore has limited scope for interpreting other populations, repeated administration, clinical outcomes, or the food-effect question.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults — NCT03342963.
• Registry record last updated 2021-05-03; status last verified 2021-04.
• Results first posted 2021-05-03.
• 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.

21. Record Summary

NCT03342963 is a completed, randomized, open-label, single-center, two-treatment, two-period crossover Phase 1 trial with enrollment of 74. It investigates a formulation comparison in Cohort 1 and food effects on ASC-01 pharmacokinetics in Cohort 2. The primary endpoint is peak plasma aripiprazole concentration in the Pharmacokinetic Analysis Set.

For Cohort 1, the posted means are 18.8 ng/mL for ASC-01 and 16.9 ng/mL for concomitant aripiprazole and sertraline. The displayed mean difference is -1.9 ng/mL for concomitant treatment relative to ASC-01; the unadjusted p-value is 0.083. The reported interval includes zero. The registry record does not report equivalence margins or a formal bioequivalence conclusion.

Serious adverse events are recorded as affecting zero participants in each listed group. Other adverse events are reported separately. The record does not provide the full statistical model, missing-data methods, original sample-size rationale, or detailed results for the other outcome measures.