Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens (NCT04849780), a randomized na study. The primary outcome is Change From Baseline Comfort Score.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, parallel-design study with two arms. It was described as multi-site, bilateral, and dispensing. The registry record lists 95 enrolled participants and a completed status. The study began on 2021-04-17, and primary completion was recorded as 2021-08-12. Its listed phase is not applicable.

Participants in Arm 1 were assigned to the test lens, ACUVUE Oasys 1-Day, for approximately 2 weeks in both eyes. Participants in Arm 2 were assigned to their habitual lens for approximately 2 weeks in both eyes and then received the test lens for approximately 2 weeks. Thus, the control-arm description includes a subsequent period wearing the test lens; the registry record does not give further detail on the timing or analytic use of those periods beyond the outcome timeframes.

The primary endpoint was change from baseline in comfort score at up to 2-week follow-up. The stated analysis population included subjects who completed all required visits without a major protocol deviation affecting a primary or secondary endpoint. The primary arm summaries contain 46 participants in Arm 1 and 39 in Arm 2. These analysis counts are not the same as the overall enrollment figure; reasons for the difference are not reported in the registry record.

The record lists three secondary endpoints: change from baseline in CLDEQ-8 score, comfort score at 2-week follow-up, and CLDEQ-8 score at 2-week follow-up. The original sample-size justification, planned analysis details beyond the posted analyses, and any interim-analysis plan are 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.

Period 1

Reasons for not completing this period:

Period 2

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

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: All subjects dispensed at least one study lens.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline Comfort Score, measured over Up to 2-Week Follow-up.

The primary endpoint is change from baseline in comfort score, measured with the Contact Lens User Experience questionnaire, or CLUE. This is a validated patient-reported outcomes questionnaire for patient experience with soft contact lenses, including comfort, vision, handling, and packaging. The described instrument is intended for a contact-lens-wearing population in the US ages 18-65.

CLUE scores are derived using Item Response Theory and are described as following a normal distribution with a population average of 60 and standard deviation of 20. Scores range from 0 to 120, with higher scores indicating a more favorable or positive response. The endpoint is calculated as the 2-week follow-up score minus the baseline score. A higher change therefore represents a more favorable change in reported comfort.

A change score focuses on how an individual’s reported experience differs from their baseline rather than only comparing scores at follow-up. The registry record reports the average change for each arm. This measure is relevant to the study question because comfort is a patient-reported experience of lens wear. It does not by itself characterize every aspect of lens performance, and the posted results do not establish how participants interpreted a particular score difference as a meaningful change.

7. Results Posted in the Registry

• Arm 2 (Subjects' Own Contact Lens): mean -0.29 versus 28.99 on control; difference -29.28 (95% CI -37.66 to -20.90), standardized effect d = -1.40; 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 CLDEQ-8 Score

• 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 deviations.
• Result:
  • Arm 2 (Subjects' Own Contact Lens): mean -1.23 versus -10.83 on control; difference 9.60 (95% CI 7.37 to 11.83), standardized effect d = 1.76; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Arm 2 (Subjects' Own Contact Lens) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Comfort Score

• 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 deviations.
• Result:
  • Arm 2 (Subjects' Own Contact Lens): mean 29.69 versus 55.88 on control; difference -26.19 (95% CI -35.36 to -17.02), standardized effect d = -1.27; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Arm 2 (Subjects' Own Contact Lens) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

CLDEQ-8 Score

• 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 deviations.
• Result:
  • Arm 2 (Subjects' Own Contact Lens): mean 21.18 versus 12.46 on control; difference 8.72 (95% CI 6.49 to 10.95), standardized effect d = 1.73; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Arm 2 (Subjects' Own Contact Lens) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes cover change from baseline and follow-up values for both comfort and CLDEQ-8. Across these endpoints, the arm-level patterns are directionally consistent with the primary result: the test-lens arm’s results are more favorable on the reported measures than the habitual-lens comparison results, taking the stated score interpretations and contrast directions into account. This coherence gives context to the primary finding, but the secondary endpoints are related measures rather than independent confirmation of the same primary estimand.

The secondary outcomes also differ in what they capture. Change scores compare follow-up with baseline, whereas follow-up scores describe the measured level at that visit. Comfort and CLDEQ-8 are distinct patient-reported measures. Consistency across them may make the overall pattern easier to describe, but does not remove uncertainty about endpoint interpretation, the study population, or the limitations of short follow-up.

Secondary comparisons generally carry less inferential weight than a prespecified primary endpoint, especially when several are tested and no multiplicity adjustment is reported. Without a stated testing hierarchy or adjustment plan, individual secondary results should be treated as exploratory rather than as separate confirmatory evidence. The registry record does not report a multiplicity strategy, and sponsor p-values are not posted for the secondary analyses. The simple re-calculated p-values are unadjusted and do not address the number of outcomes examined.

The directionally aligned secondary pattern is therefore useful descriptive context for the primary comfort comparison, but it should not be used to claim that each outcome independently establishes a definitive effect. Interpretation should account for the endpoints’ different scales, their relationship to the primary measure, and the absence of a reported plan for controlling multiplicity.

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

• Change From Baseline CLDEQ-8 Score
• Comfort Score
• CLDEQ-8 Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: each participant’s change in comfort score is measured on a numerical scale, and the posted arm summaries report means and standard deviations. A mean describes the average observed change in an arm. A standard deviation describes how dispersed participant values are around that arm’s average; it is not the uncertainty interval for the mean.

What does the unadjusted re-calculation estimate?

The re-calculation compares the two posted arm means without adjustment for other variables. It reports Arm 2 minus Arm 1, yielding an estimated mean difference of -29.28. Because a higher change score indicates a more favorable change, the negative sign means the Arm 2 average change was lower than the Arm 1 average change in this subtraction order. The confidence interval describes uncertainty around that estimated contrast under the re-calculation’s assumptions.

This is a simple summary-statistic calculation. It is not the same as the sponsor’s reported bootstrap analysis, and it does not account for any model structure or analysis choices that are not represented in the posted means and standard deviations. The registry record does not report enough detail about the sponsor’s analysis to reconstruct it fully.

What does a p-value convey?

The re-calculated unadjusted p-value is <0.001. In general, a p-value measures how incompatible the observed data are with a specified null hypothesis under the assumptions of the test. It is not the probability that the null hypothesis is true, the probability that the result happened by chance, or a measure of effect size. Here it is an unadjusted result for a simple comparison; it does not account for testing multiple endpoints or comparisons.

The sponsor’s posted primary result does not include a p-value. The re-calculated p-value should not be substituted for one. The registry record labels the sponsor analysis as non-inferiority but does not report the margin, so the posted information is insufficient to judge the non-inferiority criterion from the label alone.

Why can analysis methods produce different estimates?

Methods can differ in the quantity estimated, the direction used to define a contrast, and how uncertainty is calculated. The sponsor reports a bootstrap population mean difference of 29.279 with a 95% confidence interval from 24.602 to 33.732. The simple re-calculation reports Arm 2 minus Arm 1 as -29.28, with a 95% confidence interval from -37.66 to -20.9. The opposite signs are consistent with different contrast directions, but the interval widths also differ. The registry record does not provide enough methodological detail to attribute that difference to a particular feature of the analysis.

Bootstrapping is a general statistical approach that estimates uncertainty by repeatedly resampling observed data and recalculating a statistic. It can be useful when a direct formula for uncertainty is unsuitable or when the analysis is based on the empirical data distribution. The exact resampling procedure, number of resamples, and any adjustments used in the sponsor analysis are not reported in the registry record.

What does the analysis population mean?

The primary outcome description identifies subjects who completed all required study visits without a major protocol deviation affecting a primary or secondary endpoint. This defines the population used for the posted endpoint, but does not give a participant flow accounting or explain how missing measurements were handled. Those details are not reported in the registry record. As a general matter, excluding participants based on completion or protocol deviations can affect how well an analysis reflects all randomized participants, especially if exclusion is related to outcomes. The available record does not establish whether that concern affected this study.

The posted primary and secondary comparisons are not described as adjusted for multiple testing. In general, conducting several statistical tests increases the opportunity for at least one apparently unusual result even when no underlying differences exist. Unadjusted secondary p-values, where available, would therefore need cautious interpretation; no sponsor p-values are posted for these analyses. The registry record does not report a multiplicity strategy, a hierarchy of endpoints, or an interim-analysis plan.

11. Confidence Intervals and Precision

The re-calculated primary mean difference is -29.28, with a 95% confidence interval from -37.66 to -20.9 for Arm 2 minus Arm 1. The interval gives a range of values compatible with the observed data under the re-calculation’s assumptions. It lies below zero, consistent with the negative estimated contrast in this direction. It also indicates that the estimate is not exact: the plausible magnitude spans a range rather than a single value.

The sponsor’s bootstrap analysis reports a population mean difference of 29.279, with a 95% confidence interval from 24.602 to 33.732. That interval is on the positive side of zero and has the sponsor’s reported contrast direction. The distinct contrast direction and method mean that this interval should not be read as if it were the same estimate as the Arm 2-minus-Arm 1 re-calculation. The registry record does not provide a full account of the relationship between the two procedures.

In general, a 95% confidence interval describes the performance of an interval-generating procedure over repeated use under its assumptions; it is not a statement that there is a 95% probability that a particular fixed effect lies inside this one interval. Its width reflects both the amount of information and variability. A narrower interval generally gives more precise information about the effect than a wider interval, but precision is distinct from clinical importance.

The arm standard deviations are 26.77 in Arm 1 and 10.24 in Arm 2, indicating different observed spreads. The re-calculation uses the posted summary statistics and reports an interval for its unadjusted contrast. The primary sponsor interval comes from bootstrapping. Without further analysis details, the posted intervals should be interpreted according to their own reported methods and contrast directions, not combined or treated as direct replications of one another.

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 events. They are illustrative calculations based on the observed effect, not the trial’s original design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column gives the estimated participants per arm for a design with an 80% chance of detecting the specified effect under the planning assumptions, if that effect is the true one and the assumptions hold. The 90% power column gives the corresponding per-arm planning figure for a 90% chance. These are prospective planning quantities, not measures of how likely the completed study was to have detected an effect.

The rows consider planning for 100%, 75%, and 50% of the observed effect. A smaller effect is harder to distinguish from background variability, so planning for a smaller effect requires more participants per arm. The displayed figures are based on the observed effect in this study and should not be taken as a recommended sample size for another study without considering its goals, design, outcome variability, and analysis plan.

These calculations are not observed power. Observed power is not a useful substitute for interpreting the effect estimate and its confidence interval; the planning figures instead illustrate how assumed effect size and desired power relate to sample size under the stated assumptions.

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 = -29.280; pooled standard deviation σ = 20.892.
2. n = 2 × (1.96 + 0.842)² × 20.892² / -29.280² = 8.0, rounded up to 8 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 <- -29.28                      # observed difference in means
sigma <- 20.8919552655867                     # 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(4849780)
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 = 8 (80% power), 11 (90% power)
 75% of observed effect: n per arm = 15 (80% power), 20 (90% power)
 50% of observed effect: n per arm = 32 (80% power), 43 (90% power)
power.t.test: 9.1 
Simulated power at n = 8 per arm: 0.741 (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 sponsor’s primary analysis is reported as a bootstrap estimate of the population mean difference: 29.279, with a 95% confidence interval from 24.602 to 33.732. It is labeled as a non-inferiority analysis. No p-value or non-inferiority margin is reported with that result.

The simple re-calculation uses the posted arm means and standard deviations and defines the contrast as Arm 2 minus Arm 1. It estimates -29.28, with a 95% confidence interval from -37.66 to -20.9 and an unadjusted p-value <0.001. The opposite sign is consistent with a reversed subtraction direction, but the confidence intervals are not identical. The registry record does not report enough detail to establish whether the two analyses use the same estimand or to explain all differences in uncertainty.

The sponsor’s analysis and the re-calculation should therefore be read as distinct results. The re-calculation is not a replacement for the sponsor’s analysis, nor does its unadjusted p-value supply a missing sponsor p-value. The record does not identify a discrepancy flag, but it also does not provide the methodological detail needed to reconcile the reported intervals beyond noting the different methods and apparent direction conventions.

15. Multiplicity, Missing Data and Analysis Populations

The record lists one primary endpoint and three secondary endpoints. The posted results include multiple comparisons across these measures, but a multiplicity-control plan is not reported in the registry record. In general, when several hypotheses are tested, the chance of at least one false-positive result can increase if each test is judged separately at the same threshold. Adjustments or a prespecified testing hierarchy can address that issue, but no such approach is described in the posted record.

The primary endpoint has a sponsor-reported confidence interval but no p-value. The secondary sponsor analyses also do not report p-values. The simple re-calculations include unadjusted p-values, which do not account for the set of endpoints tested. Their statistical significance should not be treated as if multiplicity had been handled.

The outcome description states that the primary analysis population consisted of subjects who completed all required study visits without a major protocol deviation affecting a primary or secondary endpoint. The record does not report a complete account of randomized participants by analysis population, the number with missing outcome measurements, or reasons for missingness. It does not specify the missing-data method or whether any sensitivity analyses were performed. Those omissions make it difficult to assess how incomplete follow-up may have affected the estimates.

The record also does not report whether the primary analysis followed an intention-to-treat principle, how protocol deviations were adjudicated, or how participants were handled if they did not complete the planned lens periods. These are distinct analysis choices; the stated endpoint population alone does not answer them. The original sample-size justification and any interim-analysis plan are also not reported. Accordingly, the posted results can be described as reported, but the available information is insufficient to evaluate all aspects of the prespecified statistical plan.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record lists several lens-material groups and reports zero serious adverse events and zero deaths in each listed group. For other adverse events, the record reports one affected participant in the Stenofilcon A group and zero in each of the other listed groups. The at-risk counts differ across groups, and the record does not give a pooled participant-level summary for these entries.

These are descriptive counts in the posted safety record. They should not be combined across groups or interpreted as comparative event rates without knowing whether participants could contribute to multiple groups, how the groups relate to randomized treatment arms, and how events were collected and attributed. Those details are not reported in the registry record. The listed counts also do not establish whether an event was caused by a lens or whether unlisted events occurred outside the reported categories.

Zero serious events in the listed groups means that none were recorded in those entries; it does not prove that the risk of a serious event is zero. Safety interpretation is also limited by the study’s short follow-up and the available scope of reporting. The record lists no top serious-event terms.

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

The posted primary summaries show a more favorable average change in comfort in Arm 1 than in Arm 2 over the reported short-term follow-up. The simple re-calculation quantifies that contrast as Arm 2 minus Arm 1, while the sponsor’s reported bootstrap result uses a positive contrast direction. The sign convention matters: the numerical direction must be interpreted alongside the order of comparison and the fact that higher change scores indicate a more favorable change.

The estimates do not show that every participant experienced a favorable change, nor do group averages describe each individual’s response. A confidence interval communicates uncertainty in an estimated group contrast, not a guarantee about individual outcomes. The registry record does not report a threshold for a clinically important change, so statistical evidence of a between-arm difference cannot alone establish how important that difference is to participants.

The endpoint addresses reported comfort, alongside secondary measures of comfort and CLDEQ-8 symptoms. It does not measure every feature of contact-lens experience, and the results do not answer questions about long-term use. The study’s short follow-up, specified analysis population, and unavailable details about missing data and multiplicity constrain broader interpretation.

These results should not be extended automatically to other lens products, populations, or use patterns. The trial compared a specific test device with participants’ habitual lenses under the described sequence of lens wear. The registry record does not report enough information to assess all aspects of generalizability or to establish whether the findings apply beyond that setting. Statistical interpretation describes the posted estimates and their precision; it does not by itself make a treatment recommendation.

18. Why This Trial Matters Statistically

This trial illustrates why a mean difference needs its direction stated plainly. The primary re-calculation is expressed as Arm 2 minus Arm 1, so its negative estimate represents a lower average change in Arm 2. The sponsor’s estimate is positive, and the registry record does not fully explain the contrast convention. Readers need both the sign and the group order to understand what a reported difference means.

It also illustrates why an analysis based on posted summary statistics is not interchangeable with a sponsor analysis. The re-calculation uses a simple unadjusted comparison, while the sponsor reports a bootstrap population mean difference and labels the analysis non-inferiority. Methods, estimands, and interval construction matter; a similar numerical magnitude does not by itself establish that two analyses answer exactly the same question.

The primary score is patient-reported, and its interpretation depends on the scale direction: higher change indicates a more favorable change. This makes clear endpoint definitions essential when connecting statistical signs to the underlying experience being measured. The confidence intervals add information about precision that a point estimate or p-value alone cannot provide.

Finally, the registry record demonstrates the value of reporting analysis populations, missing-data methods, multiplicity plans, and non-inferiority margins. Without those details, some aspects of the inferential framework cannot be independently assessed. The posted results still permit a clear description of the observed arm summaries, while underscoring the boundary between descriptive interpretation and a complete evaluation of the original statistical plan.

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 gives limited information about participant characteristics, eligibility criteria, participant flow, and the number of randomized participants included in each analysis. Although overall enrollment is listed as 95, the primary endpoint summaries include 46 participants in Arm 1 and 39 in Arm 2. Reasons for this difference are not reported in the registry record, limiting assessment of attrition and the analysis population.

The primary endpoint population is defined by completion of required visits without a major protocol deviation affecting an endpoint. The record does not report how deviations were determined, how missing values were handled, or whether analyses using other populations were performed. The original sample-size justification, interim-analysis plan, multiplicity approach, and non-inferiority margin are also not reported.

The trial is described as single-masked, but the record does not specify which parties were masked. The control-arm description includes habitual-lens wear followed by test-lens wear, while Arm 1 received the test lens. Further details about the timing and analytic use of the periods are not reported. This limits interpretation of how the study sequence relates to each outcome comparison.

The primary outcome is subjective and reported over a short follow-up period. A clinically important difference threshold is not reported, and the sponsor’s primary estimate and the simple re-calculation have different reported contrast directions and interval widths. The record does not give enough detail to reconcile them fully. Safety reporting is presented by listed lens-material groups, without enough information to interpret overlapping exposure or produce a direct randomized-arm comparison.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens — NCT04849780.
• Registry record last updated 2022-10-10; status last verified 2022-09.
• Results first posted 2022-10-10.
• 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

NCT04849780 is a completed, randomized, single-masked, parallel-group study of ACUVUE Oasys 1-Day versus participants’ habitual contact lenses. It enrolled 95 participants and evaluated comfort and CLDEQ-8 outcomes after short-term lens wear.

The primary endpoint was change from baseline in CLUE comfort score at up to 2-week follow-up. The arm summaries show mean changes of 28.99 for Arm 1 and -0.29 for Arm 2. The sponsor reported a bootstrap population mean difference of 29.279 with a 95% confidence interval from 24.602 to 33.732. A simple unadjusted re-calculation expressed as Arm 2 minus Arm 1 gives -29.28, with a 95% confidence interval from -37.66 to -20.9.

The registry record does not report the original sample-size justification, multiplicity strategy, missing-data method, or non-inferiority margin. The posted estimates describe short-term group results in the stated analysis population; their interpretation is limited by the available methodological detail.