Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (NCT00299221), a randomized phase 4 study. The primary outcome is Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation.

2. Clinical Question

The outcome is a numerical summary of biopsy grades, with lower values representing lower scores on the specified scale. The main comparison is the mean score in the combination-therapy group relative to the mean in the monotherapy group. The posted results also include outcomes concerning survival, cytomegalovirus (CMV), and the mean biopsy score over the first year. Allograft vasculopathy is listed as a secondary outcome, but its result is not reported in the registry record. The question is therefore about the outcomes as recorded, not a broader assessment of the full benefits or risks of either treatment approach.

3. Trial Design

The registry classifies the study as a randomized, phase 4 trial with a parallel-group design and no masking. Participants were assigned to monotherapy or combination therapy. The record describes the two regimens as tacrolimus alone and tacrolimus with mycophenolate mofetil, respectively. It does not report how the random sequence was generated, whether allocation was concealed, or the details of treatment delivery and follow-up.

The registry records enrollment of 150 participants. For the primary outcome, the posted group summaries use 79 participants in the monotherapy group and 71 in the combination-therapy group. These are the denominators reported for that outcome; the record does not give an account of participant flow or explain any differences between enrollment and outcome denominators.

The study is sponsored by Newark Beth Israel Medical Center. The recorded start is 2004-04, primary completion is 2009-06, and status is completed. Its official title identifies it as the TICTAC trial, a prospective randomized trial of minimized immunosuppression in adult heart transplant recipients.

The primary outcome is the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months after transplantation. The registry also lists four secondary outcomes, including survival and CMV at one year, allograft vasculopathy, and a first-year mean biopsy score. The record does not report the trial’s original sample-size justification, planned statistical analysis details, masking procedures beyond the designation of none, or any interim-analysis plan. Those features should not be inferred from the posted outcome summaries.

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: Consent often obtained after transplant

Overall Study

Analysis population for the primary outcome, as defined in the registry: all pts, intention to treat

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 Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation, measured over 6 months.

The primary endpoint is the mean ISHLT biopsy score over the first 6 months after transplantation. Heart biopsies receive numerical scores according to their grades: grade 0 is 0 points, grade 1A is 1, grade 1B is 2, grade 2 is 3, grade 3A is 4, grade 3B is 5, and grade 4 is 6. The endpoint averages the numerical biopsy scores during the specified period for each group. The record describes 0 as the best value and 6 as the worst score.

A mean provides a group-level summary of the scores; it does not show the distribution of individual biopsy findings or how many participants had a particular grade. The standard deviations describe variation in scores around each group’s mean. A mean score can be used to compare the groups’ average biopsy findings on the same scale, while the accompanying uncertainty information helps show how precisely that comparison is estimated.

The endpoint is relevant to the trial’s stated question because the registry’s hypothesis concerns protection against rejection, and biopsy grades are the recorded measure used for this primary comparison. The registry does not report the number or timing of biopsies per participant, rules for handling repeated measurements, or how missing biopsy results were handled. The interpretation is therefore limited to the endpoint definition and summaries recorded for the first 6 months.

7. Results Posted in the Registry

• Combination Therapy: mean 0.65 versus 0.70 on control; difference -0.05 (95% CI -0.18 to 0.08), standardized effect d = -0.12; z-test p = 0.466.

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.

Percent of Patients Alive at One Year Post-transplant

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Combination Therapy: 98.6% (70/71) versus 97.5% (77/79) on control; risk difference 1.1 percentage points (95% CI -3.3 to 5.5), risk ratio 1.01 (0.97–1.06); unadjusted two-proportion z-test p = 0.624.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Combination Therapy and the control. The interval gives the range of effects that remain compatible with the data.

Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Combination Therapy: 2.8% (2/71) versus 2.5% (2/79) on control; risk difference 0.3 percentage points (95% CI -4.9 to 5.5), risk ratio 1.11 (0.16–7.69); unadjusted two-proportion z-test p = 0.914.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Combination Therapy and the control. The interval gives the range of effects that remain compatible with the data.

Mean ISHLT Biopsy Score Over First Year Post-transplant

• 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:
  • Combination Therapy: mean 0.62 versus 0.67 on control; difference -0.05 (95% CI -0.18 to 0.08), standardized effect d = -0.13; z-test p = 0.433.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Combination Therapy and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover different aspects of follow-up: survival and CMV at one year, allograft vasculopathy, and a mean biopsy score over the first year. Across the posted results, the group summaries do not show a clearly separated pattern that would change the interpretation of the primary comparison. The first-year biopsy-score comparison is directionally similar to the primary mean comparison, while the reported survival and CMV summaries are close between groups. The allograft vasculopathy result is not reported in the registry record.

These outcomes add context, but they do not answer exactly the same question as the primary endpoint. In particular, the primary endpoint concerns the first 6 months, while some secondary outcomes concern one year. Results across different follow-up periods or outcome types should not be treated as interchangeable evidence. The annual biopsy score is related to the primary score, but it uses a distinct timeframe and is designated secondary.

Unadjusted secondary results carry less weight when several outcomes are considered. In general, examining multiple outcomes creates more opportunities for apparently notable findings to arise by chance. A multiplicity procedure can address that issue, but the registry record does not report whether any adjustment was planned or applied. The posted secondary p-values are identified as unadjusted, and the record does not provide a complete analysis plan describing the role of each outcome.

The secondary results should therefore be treated as supplementary descriptions rather than independent confirmation of the primary result. Their uncertainty, the limited information on analysis methods, and the absence of a reported result for one listed outcome constrain the conclusions that can be drawn from the overall pattern.

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

• Percent of Patients Alive at One Year Post-transplant
• Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant
• Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant
• Mean ISHLT Biopsy Score Over First Year Post-transplant

9. Statistical Interpretation

10. Statistical Methods Explained

Comparing group means. The primary outcome is continuous: each participant’s biopsy scores contribute to a numerical average. The posted group means are 0.7 for monotherapy and 0.65 for combination therapy. The mean difference is expressed as combination therapy minus monotherapy, so a negative estimate means that the posted average is numerically lower in the combination-therapy group. The estimated difference is -0.05 units. This direction describes the arithmetic contrast only; it does not by itself establish an important clinical difference.

The standard deviations are 0.44 for monotherapy and 0.4 for combination therapy. In general, a standard deviation describes how spread out individual values are around their group mean. It is not the uncertainty interval for the group mean or for the difference between group means. The registry also records standard errors for the group means, which describe the estimated sampling variability of those means under the calculation used. Standard deviations and standard errors answer different questions and should not be interchanged.

Uncertainty intervals. The interval for the primary mean difference runs from -0.184 to 0.084. In general, a confidence interval conveys a range of estimates compatible with the data and the method’s assumptions. An interval that includes zero is consistent with no difference, but it may also include differences in either direction. It does not show that all values in the interval are equally likely, and it does not establish equivalence. The confidence level for the primary comparison is not reported in the registry record, so the interval should not be assigned a confidence level that is not recorded.

Hypothesis tests and p-values. The posted unadjusted p-value for the primary comparison is 0.466. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or a measure of clinical importance. The registry record does not report the primary test’s full specification or a threshold for statistical significance. The word “unadjusted” indicates that the posted value is not presented as corrected for multiple comparisons.

Binary outcomes. Survival and CMV are recorded as binary outcomes, meaning that each participant either meets the recorded outcome or does not. A group percentage or count summarizes how often the outcome was recorded in that group. A risk difference expresses the difference between group proportions; a risk ratio compares the proportions as a ratio; and an odds ratio compares the odds. In general, these effect measures convey the comparison in different ways and can have quite different numerical scales. For the survival and CMV outcomes, the posted risk-difference intervals include zero. The registry also reports risk ratios and odds ratios for those outcomes, but their intervals are broad, so those relative measures are not estimated precisely.

Reported test for the first-year mean. For the secondary first-year mean biopsy score, the registry records a two-sided t-test and p=0.44. In general, a two-sided test considers departures in either direction, rather than only a difference favoring one particular group. The registry does not report an interval for this test. The separately posted unadjusted comparison gives p=0.433. These are two recorded summaries of the secondary comparison; neither makes the first-year outcome a substitute for the prespecified primary outcome.

Over-dispersion and outcome distributions. In general, over-dispersion occurs when variability in outcome data is greater than a statistical model expects. It can make uncertainty estimates too narrow if the model does not account for that extra variation. The posted primary outcome is summarized with means and standard deviations, and the binary outcomes are summarized with counts and proportions. The registry does not report a model for over-dispersion or evidence that it was assessed. It is therefore not possible to say whether an over-dispersion adjustment was considered.

Randomization and analysis population. Random allocation is intended to make treatment groups comparable on average at the start of a trial. The record labels the study randomized and identifies the primary population as all participants, intention to treat. In general, an intention-to-treat analysis aims to retain participants in their assigned groups, regardless of treatment received. The registry does not explain how this principle was applied to missing outcome data, deviations from assigned treatment, or participants without an observed biopsy score. The group denominators alone do not answer those questions.

What the posted calculations can establish. The effect estimates and p-values describe comparisons based on the recorded summaries. General statistical interpretation depends on how participants were randomized, measured, followed, and analyzed, as well as on the appropriateness of the calculation’s assumptions. The registry record does not provide all those details. Results should therefore be read as estimates from the posted record rather than as a complete reconstruction of the trial’s statistical analysis plan.

11. Confidence Intervals and Precision

The primary mean difference is -0.05 units, with an interval from -0.184 to 0.084. This interval spans zero and includes both a lower mean score in the combination-therapy group and a higher mean score in that group, relative to monotherapy. Its width indicates that the estimate does not narrowly determine the magnitude or direction of the difference. The confidence level for this primary interval is not reported in the registry record.

In general, an interval communicates uncertainty around an estimated effect, not the range of individual participant outcomes. It is also not a guarantee that the true effect lies within the endpoints. The interval’s interpretation depends on the method and assumptions used to calculate it. For the primary comparison, the registry does not report enough detail to verify those assumptions or identify a confidence level.

The standard deviations of 0.44 and 0.4 describe observed variation in biopsy scores within the two groups; they are not confidence intervals. The standard errors, 0.050 and 0.048, describe uncertainty in the estimated group means under the calculation recorded. The interval for the mean difference is the more direct summary of uncertainty about the between-group contrast.

Other outcomes also have intervals that include no difference on their reported scales. The survival risk-difference interval runs from -0.033 to 0.055, and the CMV risk-difference interval runs from -0.049 to 0.055. The first-year mean-score interval runs from -0.175 to 0.075. These estimates are not precise enough to exclude effects in either direction. The intervals should be considered alongside the number of participants and, for binary outcomes, the small number of recorded events. They do not establish that the groups are equivalent.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for the continuous and binary outcomes in this trial; they are not total event counts. The event-total convention applies to time-to-event calculations, and the posted outcomes are not identified as time-to-event outcomes. The planning exercise uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers effects equal to 100%, 75%, and 50% of the observed effect. The trial’s own original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the stated effect under those assumptions, if that effect were present. The 90% power column uses a higher chance of detection and therefore generally calls for more participants per arm. These are planning illustrations, not the trial’s observed power.

Each row uses a different fraction of the observed effect as the effect to detect. A smaller effect is harder to distinguish from random variation, so the calculation requires more participants. The figures depend on the planning assumptions and on treating the observed effect as the starting point for the illustration. They should not be interpreted as the actual trial’s planned enrollment target, nor as evidence that the trial was or was not adequately designed. The original design rationale is not reported in the registry record.

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 = -0.050; pooled standard deviation σ = 0.422.
2. n = 2 × (1.96 + 0.842)² × 0.422² / -0.050² = 1,115.8, rounded up to 1,116 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 <- -0.0499999999999999                      # observed difference in means
sigma <- 0.421554395194865                     # 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(299221)
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 = 1,116 (80% power), 1,494 (90% power)
 75% of observed effect: n per arm = 1,984 (80% power), 2,656 (90% power)
 50% of observed effect: n per arm = 4,464 (80% power), 5,976 (90% power)
power.t.test: 1116.8 
Simulated power at n = 1,116 per arm: 0.804 (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 lists four secondary outcomes in addition to the primary endpoint: survival at one year, CMV at one year, allograft vasculopathy at one year, and mean biopsy score over the first year. When several outcomes are examined, the chance of obtaining at least one apparently unusual result can increase. In general, multiplicity methods are used to manage that issue, for example by adjusting tests or by defining a hierarchy of outcomes. The registry record does not report a multiplicity strategy, and the posted secondary comparisons are unadjusted.

The record identifies the primary population as all participants, intention to treat. This is useful information about the intended analysis population, but it does not describe how participants were handled in every analysis. The posted denominators for the primary outcome are 79 and 71. The registry does not report a participant-flow account, reasons for unavailable outcomes, or whether the same participants contributed to each secondary endpoint.

Missing-data methods are not reported in the registry record. It is not stated whether missing biopsy measurements or other unavailable outcomes were imputed, excluded, or handled by another method. The record also does not explain how repeated biopsy results were combined beyond defining the endpoint as a mean score over the specified period. These omissions limit assessment of potential bias arising from missing observations or differences in follow-up.

The registry does not report the full statistical analysis plan, including prespecified model details, covariate adjustment, subgroup analyses, or interim analyses. Their absence from the record should not be taken as evidence that a particular method was or was not used. The posted summaries support interpretation of the reported comparisons, but they are insufficient to reconstruct every analytical decision or to assess all risks associated with outcome selection and missing data.

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

Serious events with the highest arm-level rate: death (2.5%).

The serious adverse event summaries report 2 affected participants among 79 at risk in the monotherapy group and 1 among 71 at risk in the combination-therapy group. The registry lists death as a top serious adverse event term at 2.5%. It also records zero participants with other adverse events in each group. These figures should be read as recorded counts, not as a complete characterization of safety over time.

The registry does not report death counts in the group-level death fields, and the cause, timing, relatedness to treatment, and clinical detail of the serious events are not described in the record. It also does not provide a comparative statistical analysis of these events. The percentage attached to the death term should not be used to infer unreported group-specific counts or circumstances.

In general, adverse-event counts describe events recorded under the registry’s definitions and follow-up. Small counts provide limited information about the frequency and range of uncommon events. The posted summaries therefore offer a narrow safety description and do not establish the overall safety profile of either regimen.

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

The primary result is an estimated mean-score difference of -0.05 units, with an interval from -0.184 to 0.084 and an unadjusted p-value of 0.466. The group means are close on the recorded biopsy scale, but the estimate remains uncertain. The interval includes differences in either direction, so the data do not establish a precise effect or demonstrate that the groups are equivalent.

The trial’s stated hypothesis concerned similar protection against rejection with less intense immunosuppression. Similarity is not established simply because a conventional test does not produce a small p-value. Equivalence or non-inferiority requires a margin defining what difference would be considered acceptably small, together with an analysis designed to assess that margin. Such a margin and analysis are not reported in the registry record. The posted primary result therefore cannot, on its own, be interpreted as proof of similar protection.

The secondary results provide additional descriptions but do not remove the primary uncertainty. They include one-year survival and CMV outcomes and a first-year biopsy-score summary; the result for listed allograft vasculopathy is not reported in the registry record. The secondary comparisons are unadjusted, and the record does not describe how multiplicity was addressed. They should not be treated as multiple independent confirmations.

The results also do not establish what happened outside the outcomes and follow-up periods recorded. The registry does not report important details such as missing-data handling, participant flow, or the full analysis plan. Nor do the group summaries show individual biopsy-score distributions. The interpretation is therefore limited to the posted averages, counts, and comparisons.

These findings describe statistical estimates from a randomized trial record; they are not medical advice and do not determine which regimen is appropriate for an individual. No treatment recommendation follows from the posted summaries alone.

17. Why This Trial Matters Statistically

This trial is statistically informative because it makes the distinction between an estimate and a conclusion about similarity especially important. The primary comparison is numerically close to zero, but its interval spans zero and effects in either direction. A non-significant test is not, by itself, evidence that two treatments are equivalent. Readers need to know the prespecified margin and analysis if the intended question is whether a less intensive regimen preserves outcomes within an acceptable range; those details are not reported in the registry record.

The outcome also illustrates why the measurement scale matters. Biopsy grades are converted to numerical scores, and the primary endpoint averages those scores over a defined period. A group mean is useful for comparing average scores, but it can conceal variation among participants and the distribution of biopsy grades. The standard deviations and interval add information about variability and uncertainty, but they do not replace the underlying outcome detail.

Randomization and an intention-to-treat population are relevant design features, yet they do not answer every question about analysis quality. Information about allocation procedures, missing data, participant flow, multiplicity, and the original sample-size rationale is not reported in the registry record. The case shows how much interpretation depends not only on a p-value but also on the design, endpoint definition, precision, and availability of the analysis plan.

Finally, the secondary outcomes span different types of measures and timeframes. Their unadjusted results are useful context, but they should not be combined into a single claim or treated as a substitute for the primary comparison. The record supports a careful account of what was measured and estimated, while leaving important questions about analysis and precision unresolved.

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 leaves important trial details unclear. It identifies the study as randomized and unmasked, but does not report the random-sequence method, allocation concealment, or other procedures that could help assess implementation. It does not provide a participant-flow account or explain the outcome denominators. These omissions limit assessment of how well the recorded groups and results reflect the full randomized cohort.

Missing-data handling is not reported. This matters for an endpoint based on biopsy scores over a period of follow-up, because the record does not explain whether participants with missing measurements were excluded, imputed, or otherwise accounted for. The method for combining repeated biopsy scores is described as a mean, but the number and timing of observations and rules for incomplete records are not provided.

The original sample-size justification and full statistical analysis plan are not reported. The registry does not specify a target difference for the primary endpoint, an equivalence or non-inferiority margin, or a plan for multiple outcomes. This prevents assessment of whether the trial was designed to establish similarity and how the outcome analyses were selected or prioritized. The planning illustrations based on observed effects do not fill that gap.

The record contains a limited set of outcome summaries. It does not report the allograft vasculopathy result, and the adverse-event details lack information about timing, cause, and treatment relatedness. It also does not present distributions of individual biopsy scores. These limits mean that the posted estimates should be interpreted as a partial statistical record, not a complete account of trial conduct, outcomes, or safety.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients — NCT00299221.
• Registry record last updated 2015-05-28; status last verified 2015-05.
• Results first posted 2015-05-28.
• 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

The registry describes a completed, randomized, unmasked, parallel-group phase 4 trial sponsored by Newark Beth Israel Medical Center. It records enrollment of 150 and compares tacrolimus alone with tacrolimus plus mycophenolate mofetil in adult heart transplant recipients.

The primary outcome is the mean ISHLT biopsy score over the first 6 months after transplantation. The posted means are 0.7 and 0.65, with a mean difference of -0.05 and an interval from -0.184 to 0.084. The unadjusted p-value is 0.466. The record also includes secondary outcome summaries, but the result for allograft vasculopathy is not reported in the registry record.

The registry identifies the primary analysis population as all participants, intention to treat. It does not report the original sample-size justification, full analysis plan, missing-data methods, or multiplicity strategy. The primary estimate is therefore best read as a comparison with uncertainty, not as proof of equivalence.