Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) (NCT00663858), a randomized phase 3 study. The primary outcome is International Prostate Symptom Score (IPSS).

2. Clinical Question

The clinical question is whether the 52-week symptom-score results differed among the two active-treatment groups and the placebo group. IPSS is a patient questionnaire about urinary symptoms associated with BPH, so the endpoint represents reported symptoms rather than a direct measurement of prostate size or another clinical feature. The scale runs from 0, best, to 35, worst. A decrease therefore indicates a lower score on this symptom scale, but the observed changes alone do not establish why scores changed or whether a difference between groups is attributable to treatment.

The registry record identifies the study as a randomized, parallel-group, quadruple-masked phase 3 study. It lists 420 enrolled participants, but the primary-outcome arm counts are 207, 104, and 100. The record does not explain the difference between enrollment and those outcome counts. It also does not report enough eligibility or analysis-population detail to determine precisely which participants contributed to each posted outcome summary.

3. Trial Design

This was a randomized, parallel-group phase 3 study with quadruple masking. Its official title describes a double-blind, placebo-controlled efficacy study; the summary likewise describes a double-blind portion from week 0 to week 52. The registry lists an enrollment of 420 and a completed status. It records a start in 2008-03 and primary completion in 2009-09. The sponsor is AEterna Zentaris.

Three groups appear in the primary outcome results: Cetrorelix 78+78, CET 78+Placebo, and placebo. The intervention list also names Cetrorelix 78 + Placebo. The registry record does not supply descriptions for the arms that would explain the dosing notation, and no allocation ratio is reported. The summary says study medication, either cetrorelix pamoate or placebo, was administered by intramuscular injection in the buttocks.

The primary outcome timeframe is baseline and 52 weeks. The summary describes a subsequent open-label period from week 52 to week 90, during which participants completing the double-blind portion were eligible to receive active drug. This design detail is relevant when interpreting the 52-week endpoint: it is the outcome recorded at the end of the described double-blind period, not a comparison from the open-label period.

The outcome summaries list 207 participants in Cetrorelix 78+78, 104 in CET 78+Placebo, and 100 in placebo. For adverse events, the at-risk counts are 212, 106, and 102, respectively. The registry record does not explain why these counts differ from one another or from the enrollment total. It also does not report the original design assumptions, the sample-size justification, or the planned statistical analysis in enough detail to reconstruct the study’s design rationale.

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:

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as International Prostate Symptom Score (IPSS), measured over Baseline and 52 weeks.

The primary endpoint was the International Prostate Symptom Score (IPSS), a patient questionnaire assessing seven BPH-related symptoms: incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, and nocturia. Each item is described on a scale from 0, best, to 5, worst; the overall score ranges from 0, best, to 35, worst. The registry lists the outcome as a mean, with standard deviation as the measure of spread, at baseline and 52 weeks.

Using a symptom questionnaire makes the endpoint directly relevant to the symptoms the study set out to assess. It captures the participant’s reported symptom experience across several aspects of urination rather than relying on a single symptom. Because lower scores are better on the stated scale, negative mean changes indicate lower scores at the endpoint relative to baseline. The arm summaries report mean changes of -6.2, -5.1, and -5.7 for Cetrorelix 78+78, CET 78+Placebo, and placebo, respectively.

Those changes are group averages. They do not show how every participant’s score changed, and the standard deviations indicate that individual results varied around the means. Nor do the mean changes alone establish a treatment effect: interpretation requires a comparison between groups and attention to the analysis method, uncertainty, missing outcome information, and the study’s reported analysis. The registry record does not report a threshold for a clinically important IPSS difference.

7. Results Posted in the Registry

• Cetrorelix 78+78: mean -6.20 versus -5.10 on control; difference -1.10 (95% CI -2.36 to 0.16), standardized effect d = -0.20; z-test p = 0.087.
• Placebo: mean -5.70 versus -5.10 on control; difference -0.60 (95% CI -2.15 to 0.95), standardized effect d = -0.11; z-test p = 0.447.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a numerical symptom score, and the registry reports a mean and standard deviation for each group. A mean describes the group’s average score change. A standard deviation describes how dispersed individual measurements are around that average. The posted standard deviations for change are 5.68 for Cetrorelix 78+78, 5.18 for CET 78+Placebo, and 6.04 for placebo. They convey variation among participants, not uncertainty in the mean itself.

What does a mean difference represent?

A mean difference subtracts one group’s mean from another group’s mean, with the direction depending on which group is designated as the reference. In the simple re-calculations, CET 78+Placebo is the reference group. The Cetrorelix 78+78 comparison is -1.1, meaning the posted mean change in that group is lower than the posted mean change in the reference group by that amount. The placebo comparison is -0.6 relative to the same reference. On the IPSS scale, negative change means a decrease from baseline; a between-group difference is not the same thing as either group’s change from baseline.

The re-calculations are unadjusted comparisons from the posted summary statistics. They do not account for baseline covariates or other participant-level information. Their confidence intervals and p values are likewise based on this simple comparison, rather than on the methods used in the registry’s reported analyses. Since the registry record flags a discrepancy, those calculations should be treated as a separate descriptive check; the sponsor’s own reported analyses take precedence.

Why do the reported analyses use ANOVA and ANCOVA?

The registry lists one ANOVA and two ANCOVA comparisons, each described as a mean difference in final values. In general, ANOVA compares group means, while ANCOVA compares groups while adjusting for one or more covariates. The registry record does not state which covariates were included in the ANCOVA models, how the models were specified, or whether any other adjustments were made. It would therefore be inappropriate to infer the details of the sponsor’s adjusted analyses from the method labels alone.

The reported comparisons do not all have the same reference group or method. The ANOVA compares Cetrorelix 78+78 with placebo. One ANCOVA compares CET 78+Placebo with placebo, and another compares Cetrorelix 78+78 with CET 78+Placebo. A result from one comparison should not be treated as if it were a test of all three groups together. The distinction between an analysis of final values and a re-calculation using posted changes also matters: the registry record does not report enough detail to reconcile those estimates exactly.

How should p values be understood?

A p value describes how compatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that a treatment effect is true, nor does it measure the size or clinical importance of a difference. A smaller p value is not, on its own, proof that a result is reliable or meaningful. The unadjusted re-calculation p values are 0.087 and 0.447. Among the reported analyses, the p value for the Cetrorelix 78+78 versus CET 78+Placebo ANCOVA comparison is below 0.05, while the other two reported p values are above 0.05.

These p values arise from different comparisons and, in the sponsor’s results, different methods. The registry record does not report whether the analysis plan designated a particular comparison as the primary statistical contrast or how it addressed the fact that multiple comparisons were reported. That missing context affects how a reader should interpret an isolated p value.

What does a confidence interval add?

A confidence interval gives a range of effect estimates compatible with the data under the specified method. It communicates uncertainty about the estimate, rather than just whether a p value crosses a threshold. When a confidence interval for a difference includes zero, the data are compatible with both no difference and differences in either direction at the stated confidence level. The re-calculated intervals for both comparisons include zero. The reported ANOVA interval also includes zero, while the reported ANCOVA interval for Cetrorelix 78+78 versus CET 78+Placebo lies below zero. The latter is a result from the registry’s own analysis and takes precedence over the unadjusted re-calculation because a discrepancy is flagged.

Why do spread and sample size matter?

For a continuous outcome, the precision of a mean comparison depends in part on the variability of the measurements and the number of participants contributing data. Greater variability makes it harder to estimate a group mean precisely when other factors are unchanged. More participants can improve precision, but the achieved precision also depends on the actual data and analysis. The outcome counts are 207, 104, and 100, whereas adverse-event at-risk counts are 212, 106, and 102. The registry record does not explain these different counts or identify the reasons some participants may not have contributed to a particular analysis.

Planning calculations use assumptions about the effect size, significance level, allocation, and statistical approximation. They can illustrate the sample size associated with a hypothetical target effect under stated assumptions; they do not establish that the original trial was designed that way. The original sample-size justification and the trial’s own planning assumptions are not reported in the registry record. The planning illustrations are not observed power.

10. Confidence Intervals and Precision

The re-calculated mean difference for Cetrorelix 78+78 versus CET 78+Placebo is -1.1. Its confidence interval extends from a negative value to a positive value, so it includes zero. The interval therefore reflects uncertainty about the direction and size of the unadjusted difference. The unadjusted p value is 0.087. For placebo versus CET 78+Placebo, the re-calculated mean difference is -0.6; its interval also includes zero, and the unadjusted p value is 0.447. Neither simple re-calculation provides a precise estimate that excludes no difference.

The registry’s reported results have their own uncertainty intervals. The ANOVA estimate for Cetrorelix 78+78 versus placebo is -0.592, with a 95% confidence interval from -1.894 to 0.709. This interval includes zero. The reported ANCOVA comparison of Cetrorelix 78+78 with CET 78+Placebo is -1.324, with a 95% confidence interval from -2.542 to -0.106. That interval lies below zero. The ANCOVA result for CET 78+Placebo versus placebo has a lower endpoint recorded in the registry as “-0709” and an upper endpoint of 2.132; the lower endpoint is not formatted as a conventional decimal in the record, so it should not be silently corrected.

A confidence interval is not a guarantee that the true difference falls within the displayed limits. It is a method for conveying the uncertainty of an estimate under an analysis and its assumptions. These intervals also do not describe the range of individual participant changes. Standard deviations describe variation among individual outcomes, while confidence intervals concern uncertainty in a group-level estimate.

The difference between the re-calculated and reported intervals reflects that they are not interchangeable analyses. The re-calculations use posted change summaries and are unadjusted; the registry reports ANOVA and ANCOVA analyses of final values. Since the registry record flags a discrepancy, interpretation should prioritize the sponsor’s own analyses while recognizing that their model details and analysis populations are not reported in the registry record.

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, not total events. They are illustrations based on the observed effect, not the trial’s own original design assumptions. The calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The registry record does not report the trial’s original sample-size justification or its original design assumptions.

The 80% power column gives the estimated number of participants per arm under those planning assumptions for a hypothetical design with an 80% chance of detecting the specified effect, if the assumptions hold. The 90% power column gives the corresponding number per arm for a design with a 90% chance under those assumptions. These are planning targets, not a description of what happened in the completed study.

For the Cetrorelix 78+78 comparison, the planning illustration lists 396 participants per arm for 80% power and 529 per arm for 90% power when planning for 100% of the observed effect. Planning for 75% of the observed effect gives 703 and 941 participants per arm, respectively; planning for 50% gives 1,581 and 2,116. For the placebo comparison, the corresponding figures are 1,377 and 1,843 for 100% of the observed effect, 2,447 and 3,276 for 75%, and 5,505 and 7,370 for 50%.

The general pattern is that a smaller target effect requires more participants to detect it under the same assumptions. These planning calculations are not observed power: they do not measure the probability that the completed study detected an effect after its results were known.

12. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = -1.100; pooled standard deviation σ = 5.518.
2. n = 2 × (1.96 + 0.842)² × 5.518² / -1.100² = 395.1, rounded up to 396 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1.1                      # observed difference in means
sigma <- 5.51836932435661                     # 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(663858)
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 = 396 (80% power), 529 (90% power)
 75% of observed effect: n per arm = 703 (80% power), 941 (90% power)
 50% of observed effect: n per arm = 1,581 (80% power), 2,116 (90% power)
power.t.test: 396 
Simulated power at n = 396 per arm: 0.800 (20000 replicates)

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

13. Analyses Reported by the Sponsor

The registry’s reported analyses and the simple re-calculations are not identical analyses. The re-calculations compare the posted mean changes using an unadjusted approach. The registry reports comparisons of final values using ANOVA or ANCOVA. The record does not report enough model detail, including the ANCOVA covariates, to reproduce those sponsor analyses from the posted summaries.

For Cetrorelix 78+78 versus CET 78+Placebo, the unadjusted re-calculation gives a mean difference of -1.1, a confidence interval that includes zero, and p = 0.087. The sponsor’s reported ANCOVA gives -1.324, with a 95% confidence interval from -2.542 to -0.106 and p = 0.033. The sponsor’s reported result is therefore different in estimate and inferential conclusion from the simple re-calculation.

The discrepancy flag means the sponsor’s own analysis takes precedence. The re-calculation is best read as a check based on the posted summary statistics, not as a substitute or correction for the reported analysis. The record does not explain the discrepancy or provide sufficient information to determine exactly which analytic choices account for it. The other reported comparisons also use different methods or reference groups, so their results should not be conflated with this pairwise comparison.

14. Multiplicity, Missing Data and Analysis Populations

The registry reports three pairwise analyses: an ANOVA comparing Cetrorelix 78+78 with placebo, an ANCOVA comparing CET 78+Placebo with placebo, and an ANCOVA comparing Cetrorelix 78+78 with CET 78+Placebo. The reported p values differ across those comparisons. When multiple comparisons are examined, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for multiplicity. The registry record does not report a multiplicity adjustment, a hierarchy of comparisons, or another plan for interpreting the set of tests. It is therefore not reported in the registry record whether or how multiplicity was addressed.

The record lists one primary outcome measure and no posted secondary outcomes. That does not establish that the protocol contained no other outcomes or analyses; those details are not reported in the registry record. The analysis plan, including any prespecified contrasts or decisions about the principal comparison, is not reported in the registry record. The reported analyses should consequently be read as the comparisons available in the record, without assuming that their status as confirmatory or exploratory is known.

Missing-data handling is also not reported in the registry record. The outcome summaries include 207 participants for Cetrorelix 78+78, 104 for CET 78+Placebo, and 100 for placebo, while the record lists 420 enrolled. It does not explain the relationship between enrollment and the outcome counts, describe missing 52-week values, or state whether missing observations were imputed, excluded, or handled by another method.

The adverse-event at-risk counts are 212, 106, and 102. These differ from the primary-outcome counts, and the registry record does not explain why. The analysis population for each reported ANOVA or ANCOVA is not reported in the registry record. It is also not reported whether the analyses followed an intention-to-treat principle, a per-protocol definition, or another population rule. Without these details, readers cannot fully assess how exclusions, missing measurements, or analysis-population decisions may have affected the results.

15. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: myocardial infartion (2.0%), cardiac failure (1.0%), completed suicide (1.0%), dyspnoea (1.0%), arthritis (0.9%).

The registry lists serious adverse events among 212 participants at risk in Cetrorelix 78+78, 106 in CET 78+Placebo, and 102 in placebo. The corresponding numbers with a serious adverse event are 8, 7, and 5. These are counts, not estimates of a causal effect, and the record does not provide a statistical comparison or confidence intervals for them. The at-risk denominators differ from the primary-outcome counts; the reason is not reported in the registry record.

The registry also lists 10, 5, and 6 participants with other adverse events in the three groups, respectively. These counts should not be combined with the serious-event counts: they are posted as a separate category. The registry identifies serious-event terms including “Myocardial infartion” at 2.0%, “Cardiac failure” at 1.0%, “Completed suicide” at 1.0%, “Dyspnoea” at 1.0%, “Arthritis” at 0.9%, and “Bronchopneumonia” at 0.9%. The record does not provide arm-specific counts for these terms in the listed information.

Deaths are not reported in the registry record; a missing value should not be interpreted as zero deaths. The event counts alone do not establish whether an event was caused by treatment, and the record does not supply additional context for assessing timing, severity beyond the serious-event classification, or attribution.

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

The posted primary-outcome summaries show mean IPSS decreases from baseline in all three groups at 52 weeks: -6.2 for Cetrorelix 78+78, -5.1 for CET 78+Placebo, and -5.7 for placebo. Because lower IPSS scores represent fewer symptoms on the stated scale, these negative mean changes indicate lower average scores at the endpoint. They are group averages, not a description of every participant’s experience.

The simple unadjusted comparison of Cetrorelix 78+78 with CET 78+Placebo produces an estimate whose confidence interval includes zero. The registry’s own ANCOVA for the same pair reports a difference of -1.324, with a 95% confidence interval from -2.542 to -0.106 and p = 0.033. Under the discrepancy flag, the sponsor’s reported analysis takes precedence. The other registry comparisons do not show the same pattern: the ANOVA comparison of Cetrorelix 78+78 with placebo has an interval that includes zero, and the ANCOVA comparison of CET 78+Placebo with placebo has a reported p value of 0.325.

These results do not establish that a treatment works or does not work. They describe reported average symptom-score changes and statistical comparisons, with uncertainty and differences in analytic method. The record does not report a clinically important difference threshold, so the clinical importance of the estimated differences cannot be determined from these results alone. It also does not report enough information about missing outcomes, analysis populations, the covariates used in ANCOVA, or multiplicity handling to resolve those aspects of interpretation.

The findings concern the 52-week primary endpoint in the described double-blind portion. The study summary says that eligible participants could receive active drug in an open-label period from week 52 to week 90, but the posted primary outcome results do not establish a comparative result for that later period. The study’s findings should therefore be understood within the reported outcome timeframe and the limitations of the registry information.

17. Why This Trial Matters Statistically

This study illustrates why a posted mean change, a between-group estimate, and a sponsor-reported analysis answer related but distinct questions. The arm summaries show the average score change within each group. A pairwise difference asks how those group averages compare. An adjusted analysis may use participant-level information that cannot be reconstructed from group means and standard deviations alone.

The contrast between the unadjusted re-calculation and the registry’s ANCOVA comparison is statistically important. For Cetrorelix 78+78 versus CET 78+Placebo, the unadjusted re-calculation has a confidence interval that includes zero, while the sponsor’s reported ANCOVA interval lies below zero. The registry record flags a discrepancy, so the sponsor’s own result takes precedence. At the same time, the record does not explain the adjustment model or the source of the discrepancy. This makes transparency about analysis methods essential to interpreting posted results.

The record also demonstrates why uncertainty matters more than a binary reading of a p value. A point estimate gives a single summary, while its confidence interval shows the range of values compatible with the data and method. The reported comparisons do not all have the same interval pattern, reference group, or statistical method. Looking across them, rather than isolating one result, gives a more complete statistical account.

Finally, the study’s posted counts and analysis details leave important questions unanswered. The primary outcome counts differ from enrollment and from adverse-event denominators, while the record does not explain the analysis populations, missing-data handling, or multiplicity plan. These gaps do not erase the reported findings, but they limit how completely readers can evaluate their precision and robustness.

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 original sample-size justification or the trial’s design assumptions. The planning calculations are illustrations based on observed effects and stated assumptions, not evidence about how the study was originally designed. The record also does not explain why the outcome counts—207, 104, and 100—differ from the enrollment of 420, or why the adverse-event at-risk counts are 212, 106, and 102.

The statistical methods are incompletely described. The record labels two comparisons as ANCOVA but does not state the covariates or full model specification. It does not explain the discrepancy between the simple re-calculations and the sponsor’s own analyses. It also does not report the multiplicity approach, the analysis populations, or how missing 52-week measurements were handled. These omissions make it difficult to reproduce or fully assess the reported analyses.

The record lists no secondary outcomes, but this does not establish whether the original protocol included other measures or analyses. It does not report a clinically important difference threshold for IPSS, so the clinical importance of the group differences cannot be judged from the statistical results alone. The arm names do not have accompanying descriptions, leaving the dosing notation unclear. The registry’s lower confidence-limit entry for one ANCOVA is recorded as “-0709,” which is not formatted as a conventional decimal and should not be silently interpreted as a corrected value.

Safety information is also limited. The record gives counts for participants with serious and other adverse events and lists several serious-event terms, but the listed terms are not broken down by arm. Deaths are not reported in the registry record. The available counts do not establish causation, and the registry record does not provide additional detail needed to interpret event timing or attribution.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) — NCT00663858.
• Registry record last updated 2011-01-17; status last verified 2010-12.
• Results first posted 2011-01-17.
• 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

NCT00663858 is a completed, randomized, parallel-group, quadruple-masked phase 3 study sponsored by AEterna Zentaris. It enrolled 420 participants and compared Cetrorelix 78+78, CET 78+Placebo, and placebo. The primary outcome was mean change in IPSS at 52 weeks, with lower scores representing fewer symptoms on the stated scale.

The posted mean changes were -6.2, -5.1, and -5.7 across the three groups. The registry reports ANOVA and ANCOVA comparisons, including an ANCOVA difference of -1.324 for Cetrorelix 78+78 versus CET 78+Placebo. The record flags a discrepancy between the sponsor’s analyses and simple unadjusted re-calculations; the sponsor’s own analysis takes precedence.

The registry record does not report the original sample-size justification, detailed model specifications, missing-data handling, analysis populations, or multiplicity plan. Serious adverse-event counts were 8, 7, and 5 across the groups; deaths are not reported in the registry record.