Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (NCT01508910), a randomized phase 3 study. The primary outcome is Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol.

2. Clinical Question

The registry frames the study as an assessment of safety and efficacy, including exercise capacity and anginal symptoms, in people with refractory angina and chronic myocardial ischemia. The primary endpoint focuses on exercise time rather than a direct measure of angina frequency. It compares two procedure-based arms, one receiving cells and one receiving placebo, while the separately described unblinded standard-of-care arm is not included in the primary analysis population described in the record.

3. Trial Design

This was a phase 3, randomized, double-blinded, parallel-group study with an active control and an unblinded standard-of-care arm. The registry records enrollment of 291. Its listed conditions are chronic myocardial ischemia, refractory angina pectoris, and advanced coronary heart disease. The sponsor is Lisata Therapeutics, Inc.; the recorded start is 2012-04, primary completion is 2015-11, and status is completed.

The two arms used in the primary comparison were the Treatment Arm and Active Control Arm. Both involved targeted intramyocardial delivery following granulocyte-colony stimulating factor mobilization and apheresis. The Treatment Arm received Auto-CD34+ cells, while the Active Control Arm received placebo diluent. A separate, unblinded standard-of-care arm had no study-related procedures. The registry also lists a Not Treated Arm in the adverse-event results. These arm descriptions should not be conflated: the primary analysis population is specifically defined as participants randomized to Treatment or Active Control.

The primary endpoint was change from baseline in total exercise time on an exercise tolerance test using the Modified Bruce Protocol, assessed at the 12 month visit. The registry defines baseline as the average of the two exercise times measured during screening. The stated primary analysis included participants randomized to the two injection arms, with baseline values substituted for missing values for participants who did not receive intramyocardial injections.

The registry record does not report the original sample-size justification, the detailed randomization procedure, the masking procedures for the separate standard-of-care arm, or the prespecified statistical analysis plan. Those details cannot be inferred from the study title or its randomized, double-blinded designation.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 291 participants provided informed consent and were screened. There were 179 screen failures. 112 participants were randomized and treated. Note that during treatment the number of arms increased from 3 to 4 to include "Not Injected" arm as 6 participants in Treatment and Active Control Arms did not have intramyocardial injections.

Randomization

Treatment

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.

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: Arms for baseline characteristics based on the Safety population as randomized i.e. randomized participants prior to treatment.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol, measured over Baseline and 12 month visit.

The primary endpoint is change from baseline in total exercise time during an exercise tolerance test using the Modified Bruce Protocol. It is expressed in seconds and assessed at the 12 month visit. The registry defines baseline as the average of the two total exercise times measured during the screening period. The reported arm-level values are means with standard deviations.

Exercise time is a continuous measure of functional capacity during a standardized exercise test. Measuring change from baseline focuses on how test performance differs from each participant’s starting assessment, rather than comparing only the follow-up values. The comparison between arms then describes the difference between the average changes. A positive mean difference favors a larger average increase in exercise time in the Treatment Arm than in the Active Control Arm, but the estimate must be interpreted with its uncertainty.

There is an important analysis detail: the primary population is described as participants randomized to the Treatment or Active Control arms, and participants not receiving intramyocardial injections had missing values imputed with their baseline values. This rule makes the assumed change for those missing observations zero. The registry record does not give additional detail about other missing data, exclusions, or sensitivity analyses. Thus, the endpoint is clinically interpretable as change in exercise-test performance, while its result also depends on the stated population and missing-value approach.

7. Results Posted in the Registry

• Treatment Arm: mean 108.70 versus 90.00 on control; difference 18.70 (95% CI -67.31 to 104.71), standardized effect d = 0.10; z-test p = 0.670.

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 in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit

• 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:
  • Treatment Arm: mean 126.50 versus 93.50 on control; difference 33.00 (95% CI -33.95 to 99.95), standardized effect d = 0.21; z-test p = 0.334.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment Arm and the control. The interval gives the range of effects that remain compatible with the data.

Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit

• Endpoint type: Event rate: events per unit of follow-up, compared as a rate ratio.
• Test: Poisson rate ratio, based on the estimated number of events and follow-up time.
• Result:
  • Treatment Arm: 8.00 versus 8.40 (angina episodes per week) on control; rate ratio 0.95 (95% CI 0.76–1.19, approximate, Poisson model); p ≈ 0.671.
• Interpretation:
  • The 95% confidence interval includes no difference (a ratio of 1), so these data do not show a statistically significant difference between Treatment Arm and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover two kinds of outcomes: exercise-test time at the six-month visit and angina episodes per week at the six-month visit. Their pattern does not substantially clarify the primary finding. The exercise-time comparison has a positive point estimate, while the angina-frequency comparison is close to equal rates; both estimates remain uncertain. Neither secondary comparison has a reported analysis in the registry record, and their unadjusted recalculations should be read as exploratory descriptions rather than as independent confirmation of the primary result.

The secondary endpoints relate to the primary endpoint by addressing similar aspects of the study’s stated aims at a different follow-up or through a different measure. Exercise time is a continuous performance measure; angina frequency is an event-rate measure. Agreement across endpoints could have strengthened a coherent interpretation, while differing patterns could have prompted questions about measurement or timing. In these posted summaries, the results do not supply a precise, consistent basis for resolving the uncertainty in the primary comparison.

Multiplicity matters because testing multiple outcomes increases the chance that at least one result appears notable by chance. The registry lists several secondary outcomes, including additional follow-up assessments and safety outcomes, but does not report a multiplicity strategy. The displayed secondary comparisons are unadjusted. They therefore carry less confirmatory weight than a prespecified primary analysis with a reported method, and they should not be treated as a collection of independent proof points. The registry record also does not report analyses for the other listed secondary outcomes.

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

• Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit
• Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit
• Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit
• Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
• Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period

9. Statistical Interpretation

10. Statistical Methods Explained

The primary result is a comparison of means for a continuous outcome. Each participant’s endpoint is the change in total exercise time from baseline to the 12 month visit. The Treatment and Active Control arm means describe the average change within each arm. The mean difference compares those averages, with a positive value indicating a larger average change in the Treatment Arm. The reported standard deviations describe variability among participant-level changes; they are not standard errors and do not directly express uncertainty in the arm means.

What does the confidence interval convey?

A confidence interval gives a range of values compatible with the data under the method used to calculate it. In repeated use of the same procedure under its assumptions, a 95% confidence interval would contain the underlying parameter in 95% of such intervals. It is not a statement that there is a 95% probability that this particular interval contains the true value. For the primary comparison, the interval spans zero, so the posted summaries do not precisely distinguish a negative difference from a positive one.

How should the p-value be read?

The unadjusted p-value measures how unusual data at least as inconsistent with a zero mean difference would be under a model in which the true difference is zero and the model assumptions hold. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The primary p-value is an unadjusted recalculation from summary statistics. It is not reported as a sponsor analysis in the registry record.

How are the secondary comparisons different?

The six-month exercise-time outcome is also continuous, so its comparison is expressed as a mean difference. Angina frequency is a count or rate outcome, for which the posted comparison is expressed as a rate ratio. A rate ratio compares the event rates between arms; a value of one represents equal rates. The registry-derived calculation uses a Poisson approach. In general, a Poisson model assumes a relationship between the mean event rate and its variance. If the data are over-dispersed, meaning their variability exceeds that assumption, standard errors can be too small and intervals too narrow unless the analysis accounts for that extra variability. The registry record does not report whether over-dispersion was assessed or whether a different model was used by the sponsor.

The listed recalculations are unadjusted and use posted summary values. They should not be mistaken for adjusted analyses or for the trial’s complete statistical analysis. The registry record does not report the sponsor’s analysis methods for these endpoints, multiplicity handling, or sensitivity analyses. For the primary outcome, the stated imputation replaces missing values for participants who did not receive injections with their baseline values. The record does not describe other missing-data procedures.

What do planning illustrations represent?

The planning illustrations use the observed effect as a reference and show hypothetical participant requirements under stated assumptions. They are not a reconstruction of the original trial design, whose sample-size assumptions are not reported in the registry record. The listed assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the listed convention would be total events, while the illustrations for other outcomes are participants per arm. The results discussed for this trial are for the continuous and rate outcomes, so their planning figures are per arm.

These methods answer different questions. The point estimate describes the observed contrast, the confidence interval describes its precision, and the p-value quantifies compatibility with a zero-effect model under assumptions. The planning illustrations address hypothetical future study sizes for specified effects and power targets. None of these quantities alone establishes clinical importance or replaces a prespecified, fully reported trial analysis.

11. Confidence Intervals and Precision

The primary mean difference is 18.7 seconds, and its 95% confidence interval runs from -67.31 to 104.7 seconds. Because the interval crosses zero, it includes values corresponding to a smaller average change in the Treatment Arm and values corresponding to a larger average change. It therefore does not pinpoint the direction of the underlying difference. The interval’s breadth also indicates substantial uncertainty about the magnitude.

The arm-level standard deviations, 194.3 seconds for the Treatment Arm and 184.7 seconds for the Active Control Arm, are large compared with the estimated between-arm difference. Standard deviations describe variation among individual changes, whereas the confidence interval reflects uncertainty about the estimated contrast. The intervals are influenced by both variability and the number of observations used in the comparison. The analyzed arm counts were 57.0 and 27.0, respectively.

A confidence interval is not a range containing every participant’s outcome, nor does it identify a threshold for clinical importance. The registry record does not report a minimum clinically important difference for exercise time, so the clinical importance of values within the interval cannot be judged against a trial-defined threshold. The unadjusted p-value of 0.67 is consistent with the interval’s failure to rule out zero, but neither statistic proves that the true difference is zero.

The interval is a recalculated unadjusted estimate based on posted summary statistics. It should be read as a description of precision under that calculation, not as a substitute for an unreported adjusted sponsor analysis. The missing-value rule for participants who did not receive injections is also relevant to what the estimate represents.

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 for hypothetical studies, not the number enrolled in the completed trial. For these outcomes, the figures are participants per arm, not total participants or total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each row considers an effect defined as a stated fraction of the observed effect. The original trial’s own sample-size assumptions are not reported in the registry record.

The 80% power column gives the participants per arm estimated to provide an 80% chance of detecting the specified effect at the stated significance level, if the planning assumptions hold. The 90% power column gives the corresponding requirement for a 90% chance. Higher target power generally requires more participants for the same assumed effect. As the assumed effect becomes smaller, the arm difference is harder to distinguish from random variation, so more participants are needed.

For the primary endpoint, the display includes planning for 100%, 75%, and 50% of the observed effect, with separate entries for 80% and 90% power. These numbers are illustrations tied to the observed point estimate and the specified assumptions; they are not recommendations or a claim about what the original investigators planned. This is not observed power: observed power calculated after seeing the result would add little information beyond the estimate and its confidence interval.

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 = 18.700; pooled standard deviation σ = 191.308.
2. n = 2 × (1.96 + 0.842)² × 191.308² / 18.700² = 1,642.9, rounded up to 1,643 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 <- 18.7                      # observed difference in means
sigma <- 191.30826165017                     # 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(1508910)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,643 (80% power), 2,200 (90% power)
 75% of observed effect: n per arm = 2,921 (80% power), 3,911 (90% power)
 50% of observed effect: n per arm = 6,572 (80% power), 8,798 (90% power)
power.t.test: 1643.9 
Simulated power at n = 1,643 per arm: 0.797 (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. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes, including exercise time, angina frequency, major adverse cardiovascular events, and serious adverse events at specified follow-up periods. It does not report a multiplicity adjustment or a hierarchy specifying which secondary tests would be confirmatory. When many outcomes are examined, the chance of at least one apparently unusual result can increase. Without a reported plan, unadjusted secondary p-values should be interpreted cautiously and cannot be treated as though each were the sole planned test.

The primary result discussed is an unadjusted recalculation from posted summary statistics. The registry record does not report a sponsor analysis for the primary endpoint among the posted analyses, nor does it provide the detailed statistical analysis plan. The record does not report whether covariates were adjusted for, whether there were interim analyses, or what other sensitivity analyses were planned or conducted. Those items cannot be inferred from the trial’s phase, randomized design, or endpoint description.

The primary population is defined as participants randomized to the Treatment or Active Control arms. For participants not receiving intramyocardial injections, missing primary values were imputed by substituting baseline values. That stated rule implies no change for those particular missing observations, but the registry record does not explain other missing-data procedures, the number of missing values, or the assumptions behind the imputation. It also does not describe analyses testing how alternative missing-data assumptions would affect the result.

Accordingly, interpretation should distinguish the stated endpoint and population from details that are not reported. The missing analysis plan, absent multiplicity description, and incomplete account of missing-data handling limit assessment of whether the recalculated comparisons match the investigators’ prespecified methods.

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: angina pectoris (39.3%), angina unstable (16.7%), acute myocardial infarction (16.7%), pericardial effusion (16.7%), pleural effusion (16.7%).

The adverse-event results list serious adverse events among participants at risk in each arm. In the Treatment Arm, 31 participants were affected among 50 at risk; in the Active Control Arm, 17 were affected among 28 at risk. The unblinded standard-of-care arm lists 22 affected among 28 at risk, and the Not Treated Arm lists 3 affected among 6 at risk. These are counts from the registry record, not a randomized comparison adjusted for differences between the groups.

The record also lists other adverse events: 48 affected among 50 at risk in the Treatment Arm, 26 among 28 in the Active Control Arm, 23 among 28 in the unblinded standard-of-care arm, and 5 among 6 in the Not Treated Arm. Serious-event terms listed include angina pectoris at 39.3%, and angina unstable, acute myocardial infarction, pericardial effusion, pleural effusion, and hypotension, each at 16.7%. These terms describe reported events; they do not establish that an intervention caused them.

Death counts are not reported in the registry record. The event counts alone do not determine comparative safety, especially because the standard-of-care and Not Treated arms differ in design from the two injection arms. The record’s posted adverse-event information should be read as descriptive, not as a causal or definitive safety comparison.

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

The primary result describes the average change in exercise-test time for the two injection arms under the stated analysis population and missing-value rule. The observed mean change was higher in the Treatment Arm than in the Active Control Arm, but the recalculated difference is imprecise. Its confidence interval includes zero and values on either side. The result therefore does not establish a clear direction or magnitude for the between-arm difference.

It would be incorrect to interpret the interval spanning zero as proof that the treatments have identical effects. The data are also compatible with a positive difference. Conversely, the positive point estimate does not establish that cell delivery caused an improvement. A point estimate is a summary of the observed contrast, and uncertainty around it is substantial. The registry record does not provide a clinically important threshold with which to assess whether a particular difference in seconds would matter to participants.

The primary comparison is between the Treatment and Active Control arms, not between the Treatment Arm and the separately listed standard-of-care group. The latter was unblinded and had no study-related procedures; its role and results should not be substituted for the active-control comparison. The endpoint is exercise-test performance, not a direct measure of all symptoms or clinical events.

The posted secondary numerical results offer additional context but are unadjusted and not reported as sponsor analyses. The safety counts are descriptive and do not by themselves establish causation or a between-arm safety difference. Overall, the registry data support a cautious reading: they report an uncertain estimate, rather than a definitive positive or null conclusion. They do not by themselves establish a treatment recommendation or resolve questions about the full benefit-risk profile.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison is interpreted through both its estimated effect and its uncertainty. The primary point estimate is positive, but the confidence interval is wide and includes zero. Reporting only the direction of the estimate would overstate what the data establish; focusing only on whether a p-value crosses a threshold would also hide the range of plausible effects.

It also shows the importance of separating trial design features from the analysis actually reported. The registry describes randomization and double blinding for the study, but the primary comparison includes only two arms, while an unblinded standard-of-care arm is separately listed. Clear identification of the analysis population and comparator prevents an inappropriate comparison across groups with different procedures.

Missing-data rules are part of the estimand’s interpretation. Replacing missing values with baseline values for participants who did not receive injections assigns no change to those observations. Without details on other missingness or sensitivity analyses, readers cannot fully assess robustness to alternative assumptions.

Finally, the registry contains multiple outcomes, but no multiplicity strategy or detailed sponsor analysis plan is reported. This underscores why secondary outcomes and safety counts should be interpreted in context rather than counted as separate confirmations. Statistical reporting is most useful when it makes the target comparison, methods, uncertainty, missing-data assumptions, and planned handling of multiple outcomes transparent.

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 posted primary comparison is a recalculation from arm-level summary statistics rather than a reported sponsor analysis. The registry record does not provide the full analysis plan, adjustment variables, or details sufficient to determine whether the recalculation reproduces the planned primary method. The primary confidence interval and p-value should therefore be understood as unadjusted summaries of the posted data.

The primary analysis population is limited to participants randomized to the Treatment and Active Control arms, even though the registry describes an additional unblinded standard-of-care arm and lists a Not Treated Arm in safety results. The primary outcome does not provide a direct comparison with standard care. Also, the stated rule substitutes baseline values for missing primary values among participants who did not receive intramyocardial injections; the record does not report other missing-data details or sensitivity analyses.

The primary interval is broad, limiting precision about the direction and size of the difference. The registry record does not report a threshold for clinical importance, so the estimated difference cannot be judged against a trial-defined meaningful change. The original sample-size rationale and any interim-analysis plan are not reported.

There are several listed secondary outcomes, but the registry record does not report analyses for all of them or explain how multiplicity was handled. The posted secondary calculations are unadjusted. Adverse-event counts are descriptive, and the registry record does not report death counts. These limitations constrain what can be concluded from the posted summaries without implying that unreported procedures or analyses were absent from the full study.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina — NCT01508910.
• Registry record last updated 2018-12-19; status last verified 2018-11.
• Results first posted 2017-02-15.
• 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

NCT01508910 is a completed phase 3 randomized, double-blinded, parallel-group study of targeted intramyocardial Auto-CD34+ cell delivery for people with refractory angina and chronic myocardial ischemia. Its primary endpoint was change in total exercise time on the Modified Bruce Protocol from baseline to the 12 month visit, comparing the Treatment Arm with the Active Control Arm.

The recalculated unadjusted mean difference was 18.7 seconds, with a 95% confidence interval from -67.31 to 104.7 seconds and an unadjusted p-value of 0.67. The interval includes zero and indicates substantial uncertainty. Secondary numerical results and adverse-event counts provide descriptive context, but the registry record does not report a detailed statistical analysis plan, multiplicity approach, or sponsor analyses for the posted endpoints.