In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) (NCT03782103), a randomized phase 3 study. The primary outcome is Bacterial Reduction - Groin.

2. Clinical Question

The registry record describes a clinical evaluation of topical skin preparation, not a study of clinical infection outcomes. The endpoint concerns recovered bacterial counts at specified skin sites and a specified time after application. It therefore answers a question about short-term antimicrobial activity under the study’s sampling conditions. It does not, on its own, answer questions about later infections, healing, or other clinical outcomes; those are not reported as the primary endpoint.

The registry lists three interventions, but the reported recalculated comparisons focus on ZuraPrep and ChloraPrep against the vehicle group. The sponsor’s reported comparison between ZuraPrep and ChloraPrep uses a different summary measure and is described as a non-inferiority analysis. The margin and detailed methods for that analysis are not reported in the registry record.

3. Trial Design

This is a phase 3, randomized, single-masked, parallel-group trial listed as completed. The registry records enrollment of 156 and gives a study start date of 2019-01-25 and primary completion date of 2019-05-12. The sponsor is Zurex Pharma, Inc. The identity of the party or parties masked is not reported in the registry record, nor are the method of sequence generation, allocation concealment, or allocation ratio.

The three intervention groups are ZuraPrep (70% IPA), ChloraPrep (CHG 2% / IPA 70%), and ZuraPrep Vehicle, described as Zurex Prep without IPA. The registry lists the primary measure as mean bacterial reduction in the groin at 30 seconds post product application. It records outcome results with an arm-level n of 156 for each of the three groups. The relationship between the overall enrollment entry and the arm-level outcome entries is not explained in the registry record, so those figures should be read as separately posted record values rather than reconciled into a participant flow.

The primary endpoint population is restricted to treated subjects meeting the stated treatment-day baseline range at each sampling site. The description also specifies two groin sampling sites per subject. Whether the analysis averaged site-level measurements, used another aggregation rule, or handled multiple observations in a different way is not reported in the registry record.

The study objective mentions abdomen and inguinal skin flora. The primary outcome presented is groin bacterial reduction, while a secondary outcome concerns bacterial counts not exceeding baseline in the abdomen and groin region. The registry lists three outcome measures and four analyses, but detailed protocols for all measures, assessment procedures, and the analysis population for each are not reported in the registry record. Dates and completion status describe the record’s study timeline; they do not establish what procedures or analyses occurred beyond those specifically posted.

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.

Before assignment: Enrollment consists of subjects that advanced from screening to randomization and treatment. Each subject had 2 test products applied bilaterally; therefore, the numbers will not add up uniformly across arms due to the pre-determined cohort/block design. Result totals will be less than than the treated number as the per subject/area/intervention anatomical site must have an acceptable baseline count/flora.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm\^2 recoveries for each sampling site (2 groin sampling sites per subject).

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: Subjects must have the following bacteria counts to entry study, for the abdomen, the allowable baseline log10 CFU/cm2 value \> 3.0; for the groin, the allowable baseline log10 CFU/cm2 value \> 5.0.

6. Primary Endpoint

The registry lists the primary outcome as Bacterial Reduction - Groin, measured over 30 seconds post product application.

The primary endpoint is mean reduction in bacterial count from baseline in the groin, expressed in log 10 CFU/cm2. It is assessed 30 seconds after product application. The registry defines a 3-log10 CFU/cm^2 reduction on the inguinal region as a success. The listed endpoint population consists of treated subjects with baseline recoveries of 5.0-7.5 log10 CFU/cm^2 at each sampling site, with two groin sampling sites per subject.

A log-scale reduction describes the change in recovered bacterial counts on a logarithmic scale rather than a simple count difference. In general, this type of endpoint can summarize antimicrobial activity across sampled skin sites, while the measurement time makes clear that it concerns an early post-application response. The registry’s success criterion gives a reference threshold for interpreting individual reductions, but the posted primary group summaries are means. They do not by themselves show how many participants met the threshold or the distribution of individual responses.

The endpoint is used to assess short-term bacterial reduction under the specified sampling conditions. It is not an infection outcome, and the registry record does not report that the endpoint predicts infection or other later clinical outcomes. Nor does the posted description explain how the two site measurements contributed to each participant’s endpoint value. That aggregation detail is not reported in the registry record.

7. Results Posted in the Registry

• Mean Log Reduction - ZP (70% IPA) - Groin: mean 4.13 versus 1.28 on control; difference 2.86 (95% CI 2.74 to 2.97), standardized effect d = 5.60; z-test p = <0.001.
• Mean Log Reduction - ChloraPrep - Groin: mean 3.64 versus 1.28 on control; difference 2.37 (95% CI 2.24 to 2.49), standardized effect d = 4.28; z-test p = <0.001.

8. Statistical Interpretation

9. Statistical Methods Explained

For a continuous endpoint, a group mean is the arithmetic average of the recorded values in that group. Here, the endpoint is mean bacterial reduction in the groin, reported in log 10 CFU/cm2. A mean summarizes the group’s central level, but it does not describe every participant’s response. The posted standard deviations give information about spread around the mean: a larger standard deviation indicates more variability in the recorded values. The standard deviations reported for the three groups are 0.4, 0.5, and 0.6.

What does a mean difference represent?

A mean difference compares the average outcome in one group with the average in a reference group. In the recalculations, the reference is ZuraPrep Vehicle. The recalculated difference for ZuraPrep (70% IPA) is 2.856, and the difference for ChloraPrep is 2.365, in the endpoint’s log 10 CFU/cm2 units. These are simple, unadjusted calculations from the posted arm summaries. They do not adjust for other variables or model the study’s sampling structure.

In general, an unadjusted comparison is a direct contrast of the reported group summaries. It can be useful for understanding the size and direction of a difference, but it may not match a prespecified trial analysis that uses a different endpoint definition, adjustment, or statistical model. The registry does not report the details needed to determine whether the sponsor’s methods accounted for site-level measurements or other design features.

What does the confidence interval add?

A confidence interval expresses uncertainty around an estimated effect under the assumptions of the calculation. The recalculated interval for ZuraPrep versus vehicle is 2.743 to 2.969; for ChloraPrep versus vehicle it is 2.242 to 2.488. In general, a narrower interval indicates greater precision for the particular estimate and method used. It does not account for biases or design features that are absent from the calculation, and it is not a range containing every individual outcome.

The unadjusted p-values for both recalculated comparisons are p < 0.001. In general, a p-value evaluates how compatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, nor does it measure the clinical importance of a difference. Because the recalculated p-values are unadjusted, they do not account for testing multiple outcomes or comparisons.

Why can the analysis choice matter?

The posted recalculations use mean reductions, whereas the sponsor’s ZuraPrep-versus-ChloraPrep analysis is described as a median difference in final values and its ZuraPrep-versus-vehicle analysis as a mean difference in final values. A median is the middle value when observations are ordered; it can represent a distribution differently from a mean, particularly when observations are skewed or contain extreme values. “Final values” and “reduction” also name different outcome summaries. These labels mean that the reported analyses cannot be assumed to estimate the same quantity.

In general, analysis choices should follow the prespecified protocol and reflect the design, endpoint, and data structure. The sponsor’s methods, non-inferiority margin, and detailed statistical plan are not reported in the registry record. The recalculations therefore serve as simple summaries from the posted arm statistics, not a replacement for the trial’s full analysis.

What does dispersion mean for these data?

Standard deviation describes the spread of observations around a mean. It is distinct from the standard error, which describes the precision of an estimated mean. In general, observations that are clustered within people or sampling sites may not be statistically independent. If repeated measurements are treated as independent when they are correlated, uncertainty can be understated. Whether such correlation is relevant to the published calculations depends on how site observations were converted to participant-level outcomes and how analyses handled them. Those details are not reported in the registry record.

Over-dispersion is a general issue when observed variability exceeds what a chosen statistical model expects. It can make model-based uncertainty too small if the model does not allow for the extra variability. The posted primary outcome is continuous and is reported with standard deviations; the registry record does not identify an over-dispersed model or provide enough methodological detail to assess that issue for the sponsor analyses.

Finally, a reported non-inferiority analysis requires a comparison against a prespecified margin, not merely an estimate close to zero or a confidence interval that includes zero. The margin and the detailed decision rule are not reported in the registry record. The posted interval can therefore be described, but the registry information does not support reconstructing the full non-inferiority conclusion.

10. Confidence Intervals and Precision

The recalculated mean differences are accompanied by 95% confidence intervals. For ZuraPrep (70% IPA) compared with ZuraPrep Vehicle, the estimate is 2.856, with an interval from 2.743 to 2.969. For ChloraPrep compared with ZuraPrep Vehicle, the estimate is 2.365, with an interval from 2.242 to 2.488. These intervals describe uncertainty for the unadjusted mean-difference calculations based on the posted arm summaries.

In general, a confidence interval is a range of values compatible with the data and the assumptions of a calculation. A narrower interval indicates a more precise estimate under those assumptions. It does not mean that there is a 95% probability that the particular interval contains the true effect, and it does not incorporate unmeasured bias or unreported analysis choices. Precision of the mean difference should also not be confused with variation among individual outcomes; the posted group standard deviations describe that spread.

The sponsor’s ZuraPrep-versus-ChloraPrep analysis is reported as a median difference in final values with a 95% interval that spans zero. The sponsor’s ZuraPrep-versus-vehicle analysis is reported as a mean difference in final values with a 95% interval whose limits are positive. The underlying estimates and interval endpoints are posted to four decimal places, so they are not repeated. The registry does not report the methods used to form these sponsor intervals.

Because the sponsor analyses use labels different from the recalculated reductions, precision should be interpreted within each analysis rather than by directly comparing interval widths across them. The registry record does not provide enough information to assess whether the sponsor intervals account for all sampling-site structure, missing measurements, or multiple comparisons.

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 planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total event counts. The calculation is a planning illustration based on the observed effect, not the trial’s original design assumptions. Those original assumptions are not reported in the registry record.

The stated illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It varies the effect to detect as a stated fraction of the observed effect. The 80% power column gives the modeled participants per arm for an 80% chance of detecting the specified effect under those assumptions; the 90% power column gives the corresponding number for a 90% chance. These are design-planning quantities, not estimates of what the completed trial’s power was.

For the ZuraPrep-versus-vehicle comparison, the listed planning figures are 1 participant per arm for 80% power and 1 for 90% power at 100% of the observed effect; 1 and 2 at 75%; and 3 and 3 at 50%. For ChloraPrep versus vehicle, the corresponding figures are 1 and 2 at 100%; 2 and 3 at 75%; and 4 and 5 at 50%. These unusually small illustrations follow from using the large observed differences and the stated normal-approximation calculation. They should not be treated as recommended trial sizes or as evidence that a small future study would be robust.

As the target effect becomes smaller, more participants are generally needed to distinguish it from random variation at a given power and significance level. The plotted planning relationship reflects that principle. In general, planning should account for uncertainty about the effect expected in a future study, the endpoint and analysis method, and practical design considerations; the registry record does not report the assumptions used for the original trial design. These calculations are not observed power.

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 = 2.856; pooled standard deviation σ = 0.510.
2. n = 2 × (1.96 + 0.842)² × 0.510² / 2.856² = 0.5, rounded up to 1 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 <- 2.856                      # observed difference in means
sigma <- 0.509901951359279                     # 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(3782103)
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 = 1 (80% power), 1 (90% power)
 75% of observed effect: n per arm = 1 (80% power), 2 (90% power)
 50% of observed effect: n per arm = 3 (80% power), 3 (90% power)
power.t.test: 2 
Simulated power at n = 1 per arm: NA (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. Analyses Reported by the Sponsor

The registry reports two sponsor analyses. The ZuraPrep-versus-ChloraPrep comparison is labeled non-inferiority and uses median difference in final values, with a 95% confidence interval that spans zero. The ZuraPrep-versus-vehicle comparison is labeled superiority and uses mean difference in final values, with a 95% confidence interval whose limits are both above zero. The sponsor’s methods and p-values are not reported in the registry record.

The recalculated results are simple unadjusted comparisons of posted mean bacterial reductions against the vehicle group. They yield a mean difference of 2.856 for ZuraPrep and 2.365 for ChloraPrep, each with a 95% confidence interval entirely above zero and p < 0.001. The sponsor’s ZuraPrep-versus-vehicle analysis and the recalculation are directionally consistent in reporting a positive difference, but they use differently labeled endpoint summaries. The ZuraPrep-versus-ChloraPrep sponsor analysis is not the same comparison as either recalculation.

The registry marks the discrepancy flag as false. The sponsor analysis therefore does not take precedence on the basis of a recorded discrepancy. Still, the sponsor’s stated analysis and the simple recalculation should not be treated as interchangeable: they differ in the named summary measure, and the sponsor methods are not posted. The sponsor’s own stated analysis is the relevant registry result for its specified analysis question; the recalculation is supplemental descriptive context.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and four analyses, while one secondary outcome is posted. The primary endpoint is groin bacterial reduction; the listed secondary outcome concerns bacterial counts not exceeding baseline in the abdomen and groin region. Detailed results for every listed measure and analysis are not reported in the registry record.

Multiplicity arises when researchers make several statistical comparisons or test several outcomes. In general, the more tests conducted, the greater the chance that at least one result appears statistically notable by chance if no adjustment or other prespecified strategy is used. The recalculated p-values are unadjusted. The registry record does not report a multiplicity plan, adjustment method, or hierarchy of outcomes, so the p-values should not be interpreted as controlling an overall error rate across all analyses.

The record does not state how missing measurements were handled, whether any participants or observations were excluded from particular analyses, or whether missingness differed among groups. Although arm-level outcome entries report n=156 for each group, that does not describe the completeness of all measurements at every site or for every endpoint. A participant flow, missing-data strategy, and sensitivity analyses are not reported in the registry record.

The endpoint population is described as treated subjects meeting a baseline bacterial-recovery criterion at each sampling site. The registry does not clarify whether the analyses followed this exact population description for every comparison, whether other analysis populations were used, or how participants failing the criterion were handled. It also does not state whether analyses were intention-to-treat, per-protocol, or another defined population.

For the sponsor’s non-inferiority analysis, the margin and decision procedure are not reported in the registry record. These details are important because a non-inferiority conclusion depends on the prespecified margin and analysis population, not just the estimated difference or whether an interval includes zero. The registry also does not report interim analyses, a stopping rule, or the statistical plan. Their presence or absence should not be inferred from the posted results.

15. 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 0% reporting threshold.

For each of the three listed groups, the registry reports 156 at risk for serious adverse events and 0 affected. It also reports 156 at risk for other adverse events and 0 affected. Deaths are reported as 0 in each group. No top serious adverse-event terms are listed.

These are registry counts for the listed safety categories. Zero reported affected participants means that the record lists no events in those categories for the posted groups; it does not establish that no unrecorded, unrecognized, or unreported events occurred. The entry does not give event definitions, the observation period for safety collection, severity grading beyond the serious-versus-other categories, or details of how events were solicited and adjudicated. Those details are not reported in the registry record.

The safety figures should be read separately from the bacterial-reduction endpoint. They do not provide information about the frequency of minor symptoms not captured under the posted categories, nor do they establish comparative safety for settings or populations outside the trial record. The posted counts are descriptive and should not be used as a substitute for a complete safety report.

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

The registry’s group summaries indicate mean groin bacterial reductions of 4.133 for ZuraPrep (70% IPA), 3.642 for ChloraPrep, and 1.277 for ZuraPrep Vehicle, measured 30 seconds after application. The recalculated mean comparisons against vehicle are positive, with 95% confidence intervals that do not include zero and unadjusted p-values of p < 0.001. These results describe the posted bacterial-reduction measure and its statistical comparison, not a patient-level clinical outcome.

The registry defines a 3-log10 CFU/cm^2 reduction as success for the inguinal region. Group means alone do not tell how many participants reached that threshold, whether results were consistent across the two groin sites, or how outcomes were distributed. The registry record does not provide those details in the posted primary summaries.

The sponsor’s analysis comparing ZuraPrep with ChloraPrep is labeled non-inferiority, but its margin and full method are not reported. The sponsor’s ZuraPrep-versus-vehicle analysis is labeled superiority and has a positive 95% interval. The sponsor’s summaries are not identical to the recalculated comparisons, and their interpretation should remain tied to the analysis definitions posted in the registry.

The results do not establish whether any preparation changes the risk of surgical-site infection or another clinical outcome, because those are not the primary endpoint. They also do not establish the durability of bacterial reduction beyond the specified 30-second assessment, or performance in settings and populations not described in the record. Such conclusions would require evidence addressing those questions.

In general, statistical evidence about a measured endpoint should be separated from a broader claim about clinical benefit or safety. The posted results support a description of group differences in short-term groin bacterial reduction under the registry’s endpoint definition. They do not, by themselves, resolve questions about clinical consequences, longer-term effects, or the full balance of outcomes.

17. Why This Trial Matters Statistically

This trial illustrates why the endpoint definition and analysis summary matter. The primary measure is a mean reduction in bacterial count at a specified skin region and time. A threshold is also stated for what counts as a successful reduction, but the posted arm summaries are means rather than proportions meeting that threshold. Those two forms of reporting answer related but distinct questions.

The record also makes clear that comparisons can differ in their estimand: the recalculations compare mean reductions against vehicle, while the sponsor reports a median difference in final values for ZuraPrep versus ChloraPrep and a mean difference in final values for ZuraPrep versus vehicle. In general, estimates should be interpreted according to the outcome, population, and contrast they actually describe. Similar labels do not guarantee that analyses target the same quantity.

Uncertainty is important even when estimates are precise. The recalculated intervals are narrow for the posted mean comparisons, but interval precision does not address missing methodological details, sampling-site dependence, multiple testing, or the clinical relevance of the endpoint. The registry’s non-inferiority analysis also highlights that an interval cannot be judged against a non-inferiority criterion without the margin and decision rule.

Finally, registry summaries offer a useful account of selected results but may not include the full statistical plan or complete outcome reporting. Reading arm means, confidence intervals, p-values, and safety counts with attention to their definitions helps separate what the recorded data show from claims that the record does not establish.

18. 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 does not report the randomization sequence method, allocation concealment, allocation ratio, or who was masked. These details limit assessment of how allocation and masking were implemented. The record lists enrollment of 156 and outcome arm entries of n=156 for each group, but does not explain their relationship or provide a participant-flow account.

The primary population is described using a baseline recovery range and two groin sampling sites per subject. The record does not state how the site measurements were combined, whether measurements were analyzed as participant-level or site-level observations, or how correlation between sites was handled. This limits independent reconstruction of the uncertainty estimates.

The primary outcome is assessed at 30 seconds post application. The record does not provide results at other time points or clinical infection outcomes. The listed secondary outcome concerns counts not exceeding baseline in the abdomen and groin region, but detailed results for all listed outcome measures are not reported in the registry record.

For sponsor analyses, the statistical methods and p-values are not reported. The non-inferiority margin and detailed decision rule are also not reported. Missing-data handling, exclusions, analysis populations, multiplicity procedures, and sensitivity analyses are not reported in the registry record. These omissions make it difficult to assess how robust the sponsor’s conclusions are to alternative analytic decisions.

The safety entry records zero affected participants for serious and other adverse events and zero deaths in each group. It does not describe event definitions, collection procedures, or observation time. Those limitations restrict what can be concluded from the posted safety counts.

Finally, the recalculated mean comparisons are unadjusted calculations from posted summaries. They may not reproduce a prespecified or full trial analysis. They provide a transparent contrast of the listed group means, but do not replace missing methodological details or establish the broader clinical meaning of the endpoint.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) — NCT03782103.
• Registry record last updated 2023-02-08; status last verified 2021-06.
• Results first posted 2022-07-21.
• 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.

22. Record Summary

NCT03782103 is a completed phase 3 randomized, single-masked, parallel-group study sponsored by Zurex Pharma, Inc. The registry records enrollment of 156, with a study start date of 2019-01-25 and primary completion date of 2019-05-12. The study evaluated ZuraPrep, ChloraPrep, and ZuraPrep Vehicle for antimicrobial effects on abdominal and inguinal skin flora.

The primary outcome is mean groin bacterial reduction 30 seconds after application, reported in log 10 CFU/cm2. The posted arm means are 4.133 for ZuraPrep (70% IPA), 3.642 for ChloraPrep, and 1.277 for vehicle. Recalculated unadjusted mean comparisons against vehicle have 95% confidence intervals above zero and p < 0.001. Sponsor analyses are reported for ZuraPrep versus ChloraPrep and ZuraPrep versus vehicle, but their detailed methods are not reported in the registry record.

The record lists zero serious adverse events, zero other adverse events, and zero deaths in each group. Important details about analysis methods, missing data, multiplicity, and the sponsor’s non-inferiority margin are not reported in the registry record.