A Study in Benign Prostatic Hyperplasia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study in Benign Prostatic Hyperplasia (NCT01152190), a randomized phase 3 study. The primary outcome is Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone.

2. Clinical Question

The registry describes the study as evaluating prostatic blood perfusion, using arterial resistive index as the primary measure. The measure was obtained by Doppler ultrasound. The endpoint focuses on a physiological measurement rather than symptoms, daily functioning, or another clinical outcome. The registry record does not report a threshold for deciding what size of change would be clinically important.

For this endpoint, a higher resistive index corresponds to greater resistance to blood flow. The comparison therefore concerns how the measure changed during the study in each group and the estimated difference in those changes. It is not, by itself, a direct assessment of how participants felt or functioned. The results should be read as evidence about this specific measurement, population, treatment period, and comparison, rather than as an answer to broader questions about every outcome relevant to benign prostatic hyperplasia.

3. Trial Design

The registry identifies NCT01152190 as a completed phase 3 study of tadalafil in benign prostatic hyperplasia. It records randomized allocation, a parallel-group model, and triple masking. The official title describes the study as double blind, while the registry design field states triple masking; which roles were masked is not reported in the registry record. The study compared tadalafil with placebo, and the planned treatment period in the stated objective was 8 weeks.

The registry lists 97 participants as the enrollment figure. For the primary outcome, the displayed group summaries use 43 participants in the placebo group and 38 in the tadalafil group. These are the numbers contributing to the posted primary endpoint summaries, not necessarily a description of every participant enrolled or of all analyses conducted. The primary analysis population required receipt of at least 1 dose, a non-missing baseline measure, and a post-baseline visit.

The registry lists a study start of 2010-09 and a primary completion of 2012-07, and marks the study completed. The registry record does not report the allocation sequence method, concealment procedures, details of the masking process, or reasons participants may not have contributed to the endpoint analysis. It also does not report the trial's original sample-size justification, its planned analysis assumptions, or whether interim analyses were conducted. Those omissions limit what can be inferred about design decisions beyond the characteristics explicitly recorded.

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: Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.

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: The Primary Analysis Population was defined as all randomized participants who received at least 1 dose of study medication.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone, measured over Baseline, Week 8.

The primary endpoint was change from baseline to the 8-week endpoint in arterial resistive index in the prostate transition zone. Arterial resistive index was measured using Doppler ultrasound and defined as the difference between peak systolic velocity and end diastolic velocity divided by peak systolic velocity. In the registry's description, the measure increases as resistance to blood flow increases. The outcome is continuous and expressed as a ratio.

Change from baseline provides a way to describe how the measured value moved during the treatment period. Comparing the groups' changes is intended to distinguish the pattern observed with tadalafil from the pattern observed with placebo, while accounting for the baseline values in the sponsor's model. The registry reports least-squares means from a mixed-model repeated-measures analysis, rather than only raw arithmetic averages.

This endpoint was selected to assess prostatic blood flow and perfusion through a vascular resistance measure. It is a physiological imaging measure, not a direct measure of symptoms or a clinical event. A change in the measure should therefore be interpreted within that scope. The registry record does not report a clinically important difference threshold or establish how a particular change in this ratio would correspond to a change in symptoms or other outcomes.

7. Results Posted in the Registry

• Tadalafil: mean 0.00 versus -0.01 on control; difference 0.01 (95% CI -0.01 to 0.03), standardized effect d = 0.26; z-test p = 0.239.

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 to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Tadalafil: mean 0.01 versus 0.00 on control; difference 0.01 (95% CI -0.01 to 0.03), standardized effect d = 0.25; z-test p = 0.239.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tadalafil and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes involving arterial resistive index at an earlier visit and in additional anatomical regions, as well as color pixel intensity in the prostate and bladder neck regions. These outcomes extend the assessment beyond the primary transition-zone measurement, but they remain related physiological or imaging measures. They do not turn the primary result into a direct assessment of symptoms or other clinical outcomes.

For the posted secondary transition-zone arterial resistive index result at the earlier visit, the sponsor reports a difference in least-squares means of 0.01 and p = 0.226. The registry also records three secondary outcomes and 12 analyses. The range of regions, visits, and measures means that the secondary findings should be considered in the context of multiple comparisons, rather than as independent confirmations of the primary result.

In general, testing multiple outcomes creates more opportunities for apparently notable results to occur by chance. An unadjusted secondary p-value does not account for that broader set of comparisons. The registry record does not report a multiplicity adjustment strategy or identify a hierarchy for testing the secondary outcomes. Consequently, secondary analyses carry less confirmatory weight than a prespecified primary result interpreted under a documented testing plan. The overall pattern across secondary endpoints cannot be treated as a single definitive conclusion when the full set of results and the multiplicity plan are not reported in the record.

Secondary measures can still provide context about whether findings align across visits or anatomical sites. However, consistency should be judged using the actual estimates, uncertainty, analysis populations, and measurement definitions for each outcome. Those details are not fully available in the summary of results. The secondary results therefore add context to the primary question, but they do not remove uncertainty about the primary estimate or establish effects on outcomes that were not measured.

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

• Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
• Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
• Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, and the registry reports least-squares mean changes from baseline. Such estimates are model-based means: they summarize the expected outcome under the fitted model after accounting for the terms included in that model. They are not necessarily identical to unadjusted averages calculated directly from the observed values.

What did the sponsor's repeated-measures model do?

The registry says the sponsor used a mixed-model repeated-measures analysis. The stated model included fixed effects for treatment, region, visit, and treatment-by-visit interaction; baseline as a covariate; a random effect of participant within treatment; and an unstructured covariance matrix. A repeated-measures model is designed to analyze measurements collected at more than one visit while representing the relationship among observations from the same participant. In general, accounting for that within-participant relationship can affect standard errors and estimates compared with treating each observation as unrelated.

Fixed effects represent modeled factors whose levels are of direct interest, such as treatment and visit. A treatment-by-visit interaction allows the treatment contrast to vary across visits rather than forcing a single common contrast at every time. A baseline covariate adjusts the model for the starting measurement. The registry's description names a random participant effect within treatment, which represents participant-level variation within the assigned groups. The record does not provide the fitted coefficients or further implementation details.

Why use an unstructured covariance matrix?

Repeated observations from one participant are often correlated. A covariance structure describes the variability of observations and how measurements at different visits relate. An unstructured matrix allows the model to estimate those relationships without imposing a simpler pattern such as equal correlations across visits. This flexibility can be useful when the pattern is not assumed to follow a particular form, but it also requires estimating more covariance features. The registry record does not report whether other covariance structures were considered or how the selected structure was checked.

How does the recalculation differ?

The posted recalculation is an unadjusted comparison derived from the available summary statistics, with an approximate pooled standard deviation. It does not reproduce the sponsor's mixed-model fit, including its repeated-measures structure, baseline adjustment, or other listed model terms. The recalculated p-value and interval are therefore complementary summaries, not a replacement for the sponsor's analysis. In general, a recalculation from summary data can be helpful for understanding the scale of an estimate, but it cannot recover all information used in a model fitted to participant-level observations.

The recalculation reports an unadjusted p-value. Unadjusted means that the value is not corrected for the number of outcome comparisons. The same caution applies to secondary endpoint comparisons when a multiplicity adjustment is not reported. When many hypotheses are considered, the chance of at least one apparently notable result can rise even if none of the underlying effects is real. General statistical practice treats exploratory, unadjusted comparisons as less conclusive than a prespecified primary comparison analyzed under a stated plan.

What do the standard errors describe?

A standard error describes the estimated sampling variability of an estimate under the analysis. It is not the spread of individual participant measurements. The registry reports a standard error of 0.006 for each primary group least-squares mean. A confidence interval uses an estimate and its uncertainty to show a range of values compatible with the data under the interval's assumptions. The sponsor's interval limits are not reported in the registry record, so the sponsor estimate's interval cannot be reconstructed from the displayed p-value alone without additional assumptions.

The primary population was defined as randomized participants who received at least 1 dose, had non-missing baseline transition-zone arterial resistive index data, and had a post-baseline visit. Thus, the posted primary outcome concerns this analysis population. The registry record does not report the number screened out by each criterion, reasons for missing measurements, or the handling of all forms of missing data. Although mixed models can use available repeated observations under assumptions about missingness, the specific missing-data assumptions and sensitivity analyses for this trial are not reported in the registry record.

What cannot be determined from the methods description?

The record does not report the original sample-size calculation or justification, the target effect used in the trial design, the planned multiplicity strategy, or the complete statistical analysis plan. It also does not describe any interim analyses or stopping rules. These details should not be inferred from the observed results or from the separate planning illustration. The registry's model description is informative about the stated primary analysis, but it does not document every analysis decision or diagnostic check.

11. Confidence Intervals and Precision

The sponsor reports a primary difference in least-squares means of 0.01 and p = 0.121. A confidence interval for this sponsor estimate is not reported in the registry record. Without its interval limits, the precision of the sponsor estimate cannot be read directly from a reported confidence interval, and the p-value alone does not show the full range of estimates compatible with the model.

The unadjusted recalculation reports a difference of 0.01 and a confidence interval that extends below and above zero. In general, a confidence interval represents a range of values compatible with the observed data and the method's assumptions. Because this recalculated interval includes zero, it does not exclude no difference under that method. Its inclusion of values on both sides of zero also indicates that the summary-data calculation does not pin down the direction of the difference with high precision.

The recalculated interval is based on approximate summary-statistic methods, while the sponsor's result comes from a repeated-measures model. Their uncertainty estimates need not match because they do not use the same model information. The recalculation should be viewed as a separate, unadjusted check rather than as the sponsor's confidence interval. The registry record does not report a clinically important difference threshold, so statistical precision cannot be translated into a judgment about clinical importance from these figures alone.

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 sample-size display gives planning illustrations in participants per arm, not total events. The outcome is continuous, so the figures concern participants per arm. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. These are planning assumptions for the illustration; the original design assumptions for the trial are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm under which a study would have an 80% probability of detecting the specified effect if that effect were truly present and the planning assumptions held. The 90% power column gives the corresponding number per arm for a higher target probability of detection. In general, choosing a higher power target requires more participants when other assumptions remain fixed.

The rows show planning for the full observed effect and for smaller fractions of that effect. The displayed requirements rise as the assumed effect becomes smaller: detecting a smaller difference is harder when variability and other assumptions are held fixed, so more participants are needed. The figures are illustrations based on the observed estimate, not evidence about the actual power of the completed trial. This is not observed power.

The curve should be read as a visual representation of the same planning relationship: smaller target effects correspond to larger participant requirements under the stated assumptions. These calculations do not establish that the observed effect is the correct value to use in a future design, and the registry record does not report the rationale for the trial's original enrollment target.

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 = 0.010; pooled standard deviation σ = 0.038.
2. n = 2 × (1.96 + 0.842)² × 0.038² / 0.010² = 229.8, rounded up to 230 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 <- 0.01                      # observed difference in means
sigma <- 0.0382582827964304                     # 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(1152190)
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 = 230 (80% power), 308 (90% power)
 75% of observed effect: n per arm = 409 (80% power), 547 (90% power)
 50% of observed effect: n per arm = 920 (80% power), 1,231 (90% power)
power.t.test: 230.7 
Simulated power at n = 230 per arm: 0.799 (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 the mixed-model repeated-measures comparison. It reports a difference in least-squares means of 0.01 and p = 0.121. The sponsor's confidence interval limits are not reported in the registry record. The sponsor result is the analysis explicitly reported for the primary endpoint.

The separate recalculation uses posted group summary statistics and an approximate pooled standard deviation. It reports a difference of 0.01, an unadjusted p-value of 0.239, and a confidence interval spanning zero. This calculation is not a reconstruction of the sponsor's repeated-measures model, so its p-value and interval are not expected to be identical to the sponsor's analysis. The registry's discrepancy flag is false; no discrepancy is identified in the record.

The recalculation can help readers inspect the approximate scale and uncertainty of the group comparison, but it does not supersede the sponsor's model-based analysis. Conversely, the absence of sponsor interval limits means that the sponsor's precision cannot be fully inspected using the registry result alone. The two analyses should be reported with their methods and kept distinct rather than selecting whichever p-value appears more favorable.

15. Multiplicity, Missing Data and Analysis Populations

The registry reports one primary endpoint and lists three secondary outcomes, with 12 analyses recorded. Multiple analyses raise a multiplicity issue: if many hypotheses are tested, the chance of at least one apparently unusual result can increase. This general concern applies even when the outcomes are related, because each test contributes another opportunity for a finding that may not replicate.

The registry record does not report a multiplicity adjustment, a formal testing hierarchy, or which secondary comparisons were designated as confirmatory versus exploratory. It also does not report the full prespecified statistical analysis plan. Without those details, the secondary p-values should be read as unadjusted evidence for individual comparisons, not as a family-wise conclusion across all outcomes. The primary comparison is the central reported test, but the record does not provide enough information to reconstruct all planned inferential decisions.

The primary analysis population is described: randomized participants who received at least 1 dose, had non-missing baseline arterial resistive index in the transition zone, and had a post-baseline visit. The group counts contributing to the posted primary summaries are not the same as the enrollment figure. The registry record does not describe the reasons for missing endpoint data, how many participants failed each analysis-population criterion, or whether the analysis population differed from any prespecified population for other analyses.

Repeated-measures models can use available measurements from participants with incomplete follow-up, depending on the model and assumptions. In general, such methods require assumptions about the relationship between missingness and observed or unobserved data. The specific assumptions, sensitivity analyses, and missing-data imputation procedures for this trial are not reported in the registry record. It is therefore not possible to assess from the record alone how robust the primary result was to alternative missing-data assumptions.

16. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cardiac arrest (2.0%), myocardial infarction (2.0%), carotid artery stenosis (2.0%), ischaemic cerebral infarction (2.0%).

The registry reports serious adverse events for 2 of 50 participants at risk in the placebo group and 0 of 47 participants at risk in the tadalafil group. It separately lists other adverse events for 4 of 50 participants at risk with placebo and 10 of 47 at risk with tadalafil. These counts describe the registry's reported categories; they should not be combined or interpreted as a causal comparison without further detail about event definitions, follow-up, and analysis.

The listed serious adverse event terms are cardiac arrest, myocardial infarction, carotid artery stenosis, and ischaemic cerebral infarction, each shown as 2.0%. The registry listing does not establish an arm attribution for these terms in the available record. Deaths are not reported in the registry record. The figures alone do not establish whether events were caused by study treatment, and the record does not provide enough detail to assess differences in event severity, timing, or relatedness.

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

The posted results describe changes in a Doppler-derived measure of vascular resistance in the prostate transition zone over the study's 8-week treatment period. The sponsor reports a difference in least-squares means of 0.01, with p = 0.121. The summary-statistic recalculation also gives a difference of 0.01, but its unadjusted p-value is 0.239 and its interval spans zero. These results should be interpreted alongside the distinction between the sponsor's model and the approximate recalculation.

The endpoint is a physiological measure: the registry explains that a higher arterial resistive index indicates greater resistance to blood flow. It is not itself a direct measurement of symptom relief, daily function, or a clinical event. The registry record does not report a threshold defining a clinically important change, so the magnitude cannot be classified as clinically meaningful or unmeaningful from these results alone.

The findings do not answer every question about tadalafil or benign prostatic hyperplasia. They pertain to the stated population, endpoint, analysis population, comparator, and treatment duration. They do not establish what would happen over a longer period, in other populations, or for outcomes not reported in this trial. The study's listed secondary outcomes add information about other imaging measures and regions, but multiplicity and incomplete reporting of the testing plan limit how strongly those findings can be combined into a single conclusion.

Statistical evidence and clinical importance are related but different concepts. A p-value addresses compatibility with a statistical model, while an effect estimate and its interval describe magnitude and uncertainty. Neither alone determines whether a difference matters to patients. The record provides no clinical importance threshold, and the sponsor's confidence interval is absent. The results therefore support a focused description of the measured endpoint, not a broad claim about benefit or lack of benefit.

18. Why This Trial Matters Statistically

This trial illustrates why an outcome's definition matters. Arterial resistive index is a specific Doppler ultrasound measure, and its interpretation has a stated direction: higher values indicate greater resistance to blood flow. Readers can therefore understand what the measurement is intended to represent without treating it as equivalent to a symptom or clinical outcome.

It also shows why the analysis method belongs alongside the estimate. The sponsor used a repeated-measures model with baseline adjustment and participant-level structure, while the posted recalculation uses an approximate method based on summary statistics. The displayed estimates are close in their reported point value, but their p-values and inferential details differ. Reporting the method helps prevent readers from treating all summaries as if they came from the same calculation.

The registry record provides a clear primary population definition and identifies the treatment groups, but it does not report a sponsor confidence interval, the original sample-size justification, or a multiplicity plan. These omissions matter for assessing precision, design rationale, and the weight of multiple secondary comparisons. The planning illustration also demonstrates that sample-size requirements depend on the assumed effect and target power; it is not a report of the completed study's observed power.

For clinical researchers, the central statistical lesson is to keep the outcome, estimate, uncertainty, analysis population, and testing context together. A numerical result detached from those features can be overinterpreted. This trial's record supports a careful account of one physiological endpoint and its uncertainty, while leaving several design and analysis details unreported.

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 primary endpoint is a physiological Doppler measure rather than a direct clinical outcome. The registry does not report a threshold for clinical importance or the relationship between a change in arterial resistive index and changes in symptoms or functioning. This limits interpretation of the practical meaning of the estimated difference.

The sponsor's confidence interval for the primary result is not reported in the registry record. The available recalculated interval is based on summary statistics and an approximate standard deviation, rather than the sponsor's repeated-measures model. That recalculation cannot supply all the uncertainty information from the original fitted analysis.

The primary analysis population required treatment exposure and endpoint data at baseline and after baseline. The registry record does not report why other participants were not included in the primary endpoint summaries, the reasons for missing data, or sensitivity analyses under alternative missing-data assumptions. The posted group counts should therefore be understood as endpoint analysis counts, not as a complete account of participation through follow-up.

The record also does not report the original sample-size rationale, planned multiplicity approach, full analysis plan, or details of interim analyses. Secondary outcomes include several regions, visits, and measurement types, while a multiplicity strategy is not reported. These gaps constrain assessment of how the findings fit the trial's prespecified inferential plan. The treatment period was 8 weeks, so the reported endpoint does not describe longer-term measurements.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study in Benign Prostatic Hyperplasia — NCT01152190.
• Registry record last updated 2013-05-20; status last verified 2013-03.
• Results first posted 2013-05-20.
• 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

NCT01152190 was a completed, randomized, parallel-group phase 3 study of tadalafil versus placebo in men with signs and symptoms of benign prostatic hyperplasia. The registry lists triple masking, an enrollment figure of 97, and a treatment period of tadalafil 5 milligrams daily for 8 weeks.

The primary outcome was change from baseline to the 8-week endpoint in arterial resistive index in the prostate transition zone. The sponsor reported a difference in least-squares means of 0.01 and p = 0.121 using mixed-model repeated measures. The sponsor confidence interval is not reported in the registry record. An unadjusted summary-statistic recalculation also gives a difference of 0.01, with p = 0.239 and an interval spanning zero.

Interpretation is limited by the physiological nature of the endpoint, the absence of a reported clinical-importance threshold and sponsor confidence interval, and unreported details about missing data, multiplicity, and the original sample-size rationale.