Improving Depression Management: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Depression Management (NCT05050227), a randomized na study. The primary outcome is Patient Health Questionnaire (PHQ-9).

2. Clinical Question

The practical motivation was a gap between the availability of medication support in VA primary care and timely access to psychotherapy. The study aimed to adapt and pilot test collaborative care models intended to improve uptake of computerized cognitive behavioral therapy. Its posted primary endpoint is a depression symptom score, not a direct measure of whether participants accessed or completed psychotherapy. The registry record does not report an outcome measuring treatment uptake among the posted results.

The question is therefore about a group-level difference in depression symptom scores at the specified follow-up, rather than a comparison of individual experiences or a test of the delivery model's effectiveness in all VA settings. The posted findings describe the participants and outcomes reported in this pilot; generalizability beyond that setting is not established by the registry record.

3. Trial Design

This was a randomized, single-masked, parallel-group study. Participants were allocated to cCBT Enhanced Collaborative Care or Usual Care. The registry lists the study phase as NA and reports that the study is completed. Enrollment was 57.

The intervention combined computerized cognitive behavioral therapy with support from a depression care manager, on top of usual care. The Usual Care arm received usual care. Further detail about the specific components of usual care, the intervention delivery schedule, or the masking procedures is not reported in the registry record. The record identifies the study as single-masked but does not specify which participants or study personnel were masked.

The primary outcome was the Patient Health Questionnaire (PHQ-9) at 3-months. The posted arm summaries report 21 participants in each group for this endpoint. These endpoint counts are distinct from overall enrollment; the registry record does not explain the relationship between the enrollment figure and the reported endpoint counts, or describe the handling of participants without endpoint data.

Other posted outcomes include the Generalized Anxiety Disorder (GAD-7), Patient Activation Measure (PAM), and PTSD Checklist for DSM-5 (PCL-5), each assessed at 3-months. The registry lists additional outcomes, but analyses for those outcomes are not posted in the record. The original protocol's sample-size rationale, planned statistical model, analysis population, missing-data procedures, and any interim analyses are not reported in the registry record. The planning illustrations associated with the posted results are not the trial's original design assumptions.

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

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 Patient Health Questionnaire (PHQ-9), measured over 3-months.

The primary endpoint is the Patient Health Questionnaire (PHQ-9), reported as a mean score at 3-months. The registry describes it as a scale commonly used to measure and categorize depression symptoms and notes that it is already administered in routine primary care at the study site. Its range is 0 to 27, with higher scores indicating more severe depression symptoms and therefore a worse outcome.

A continuous score retains gradations in reported symptom burden rather than reducing the measure to a category. Comparing group means can describe the average score difference at follow-up, while the standard deviations describe how spread out individual scores were within each arm. Neither group mean alone describes every participant's experience.

Using a routine measure can make an outcome relevant to the clinical setting in which the care model is intended to operate. The registry record does not report a threshold for a meaningful change, a responder definition, or a separate categorical endpoint for the PHQ-9. The posted result should therefore be read as a comparison of mean scores, not as the number of participants who improved or crossed a symptom category.

Because higher PHQ-9 scores indicate worse symptoms, a negative mean difference for cCBT Enhanced Collaborative Care relative to Usual Care corresponds to a lower average score in the intervention arm. That direction describes the observed score contrast; it does not by itself establish the certainty, clinical importance, or cause of the difference.

7. Results Posted in the Registry

• cCBT Enhanced Collaborative Care: mean 12.60 versus 15.20 on control; difference -2.60 (95% CI -5.72 to 0.52), standardized effect d = -0.50; z-test p = 0.102.

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.

Generalized Anxiety Disorder (GAD-7)

• 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:
  • cCBT Enhanced Collaborative Care: mean 9.60 versus 10.60 on control; difference -1.00 (95% CI -4.33 to 2.33), standardized effect d = -0.18; z-test p = 0.556.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between cCBT Enhanced Collaborative Care and the control. The interval gives the range of effects that remain compatible with the data.

Patient Activation Measure (PAM)

• 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:
  • cCBT Enhanced Collaborative Care: mean 37.50 versus 38.60 on control; difference -1.10 (95% CI -4.03 to 1.83), standardized effect d = -0.23; z-test p = 0.461.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between cCBT Enhanced Collaborative Care and the control. The interval gives the range of effects that remain compatible with the data.

PTSD Checklist for DSM-5 (PCL-5)

• 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:
  • cCBT Enhanced Collaborative Care: mean 30.10 versus 34.00 on control; difference -3.90 (95% CI -14.88 to 7.08), standardized effect d = -0.21; z-test p = 0.486.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between cCBT Enhanced Collaborative Care and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary endpoint comparisons cover anxiety symptoms, patient activation, and PTSD symptoms. The intervention-minus-control mean estimates are negative across these reported outcomes, matching the direction of the primary PHQ-9 estimate. Their confidence intervals extend across zero, so the group contrasts remain uncertain. Taken together, this is a descriptive pattern of estimates, not independent confirmation of a treatment effect.

These measures address related but distinct domains. Anxiety, activation, PTSD symptoms, and depression are not interchangeable outcomes, and a directionally similar mean contrast does not establish that the intervention had a common effect across all of them. The secondary results can add context to the primary symptom comparison, but they do not replace it or resolve its uncertainty.

Each additional outcome creates another opportunity for a result to appear noteworthy by chance when many comparisons are examined. Unadjusted p-values do not account for that multiplicity. The registry record does not report a hierarchy of secondary outcomes, a family-wise error procedure, or another multiplicity strategy. As a result, secondary findings generally warrant less weight than a prespecified primary endpoint and should be treated as exploratory unless a separate analysis plan establishes otherwise.

Several outcomes listed in the registry are not represented among the posted comparisons. The record does not explain whether those measures were not analyzed, were not reported, or were unavailable. No conclusions about those unposted outcomes should be drawn from the displayed pattern. The overall secondary evidence is best described as directionally aligned with the primary estimate but imprecise, unadjusted, and incomplete in the registry record.

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

• PROMIS Global Health
• Generalized Anxiety Disorder (GAD-7)
• Patient Activation Measure (PAM)
• PTSD Checklist for DSM-5 (PCL-5)
• Behavioral Activation for Depression Scale (BADS-SF)

9. Statistical Interpretation

10. Statistical Methods Explained

The statistical summaries describe continuous outcomes as means and standard deviations. A mean is the arithmetic average of the scores in a group. A standard deviation describes how dispersed individual scores are around that average. The endpoint means give a concise group-level description, while the standard deviations help show that participants' scores varied within each arm. These summaries do not show the full distribution, such as whether scores were skewed or clustered.

What does the mean difference represent?

The reported mean difference compares the intervention arm with Usual Care by subtracting the Usual Care mean from the intervention mean. A negative estimate means the intervention-arm mean was lower. For the PHQ-9, lower scores indicate fewer or less severe symptoms on the measure, but direction alone does not establish an effect or its importance. The mean difference is expressed in the original scale's score units, so it retains a direct relationship to the endpoint being measured.

The same kind of contrast is reported for the other continuous outcomes. Their scales measure different constructs, however, and a score-unit difference on one instrument is not directly interchangeable with the same numerical difference on another. Standardized effect-size statistics are also available in the calculations, but the registry record does not report a clinical threshold for interpreting those values. They should not be treated as a clinical response category.

How should the confidence interval be read?

A confidence interval conveys uncertainty around an estimate. In general statistical terms, an interval produced by a method with a specified coverage level would capture the true parameter in that proportion of repeated studies under the method's assumptions. It is not a range containing a known percentage of individual participant scores, and it is not a probability statement about the true value after observing these data.

For the posted mean differences, intervals that extend across zero are compatible with no average difference as well as with values in either direction. The interval's width reflects the limited precision of the estimate. The primary interval reaches from a negative value to a value just above zero; that feature is more informative than treating the point estimate alone as conclusive. The registry record does not report a prespecified decision threshold for the confidence interval.

What does the p-value add?

A p-value summarizes how incompatible the observed data are with a specified null hypothesis, assuming that hypothesis and the test's assumptions. The posted p-values are labeled unadjusted. They do not measure effect size, clinical importance, the chance that the null hypothesis is true, or the chance that the result will replicate. A p-value should be read alongside the estimate and interval, not as a stand-alone verdict.

The registry record does not report the statistical test or model used for the sponsor's original analysis. The estimates described with these results are simple, unadjusted comparisons calculated from the posted summary statistics. They are useful for describing the data, but they do not substitute for an analysis plan or an adjusted model that may have been specified elsewhere. No discrepancy between the posted results and these calculations is flagged.

Why do standard deviations matter?

Standard deviations describe variation among participant scores and are relevant to how precisely a group mean can be estimated. In general, a more variable outcome makes it harder to distinguish a group contrast from random variation when sample sizes are unchanged. This is one reason a similar mean difference can have different precision across outcomes: the amount of score variation and the endpoint sample sizes both matter.

Means and standard deviations are compact summaries, but they cannot reveal every feature of the data. The registry record does not report participant-level distributions, diagnostic checks, transformations, covariate adjustment, or sensitivity analyses. It is not possible to assess those features from the posted summaries alone.

What is not specified about the analysis?

The original statistical analysis plan, sample-size justification, analysis population, handling of missing observations, and any adjustment for multiple outcomes are not reported in the registry record. The registry also does not report whether analyses were intention-to-treat, per-protocol, or based on another defined population. These omissions limit assessment of how the reported results relate to a prespecified analysis strategy.

The outcomes are measured at 3-months, but the registry record does not give the precise timing window or report a longitudinal model using repeated measurements. The estimates therefore describe the posted endpoint comparisons and should not be interpreted as estimates of change from baseline. Baseline outcome values and baseline-adjusted results are not reported in the posted analyses.

11. Confidence Intervals and Precision

The primary mean difference is -2.6 PHQ-9 points, with a confidence interval extending from -5.715 to slightly above zero. The interval spans both a negative contrast and the possibility of no average difference. Its upper limit is just above zero, so the estimate is not separated from the null value by the interval. This is a reason to read the point estimate with caution rather than as a precise determination of the difference.

Precision refers to how narrowly the data locate an estimate, not whether the estimate is important or unbiased. The endpoint summaries include 21 participants in each arm. With these group sizes, the interval expresses substantial uncertainty relative to the point estimate. A confidence interval is not a prediction interval for individual participants; individual outcomes can vary much more widely than uncertainty about the group mean.

The secondary estimates also have intervals that extend across zero. Their widths differ across measures, reflecting the scale and variation of each outcome as well as the endpoint sample sizes. Comparing interval widths across different scales without considering their units can be misleading. Each interval is most naturally interpreted in the units of its own measure.

In general statistical terms, a confidence interval is informative when paired with its assumptions and the method that generated it. The registry record does not report the sponsor's interval method, the original analysis model, or adjustment for multiple outcomes. The posted calculations are unadjusted re-calculations from summary statistics. They communicate uncertainty in those comparisons, but cannot resolve questions about unreported design or analysis choices.

The interval does not establish that every value inside it is equally plausible, and it does not assign a probability to the true difference. It indicates that the data are not precise enough to rule out a range of plausible group contrasts under the calculation used. No threshold for a clinically important PHQ-9 difference is reported, so the interval cannot be classified as excluding or including such a threshold.

12. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm, not total participants across both arms and not total events. They are illustrations based on the observed effect, rather than the original trial's design assumptions. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; each illustration targets a stated fraction of the observed effect. The original trial's sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the target effect under those assumptions, if that effect were the true effect and the statistical model's assumptions held. The 90% power column represents a higher chance of detecting the same target effect, which generally requires more participants. These are design-planning quantities, not probabilities that the completed study's result is correct.

The rows consider planning for 100%, 75%, and 50% of the observed effect. For the primary comparison, the illustrations list 62 participants per arm for 80% power and 83 per arm for 90% power when planning for 100% of the observed effect. Planning for 75% of the observed effect lists 110 per arm for 80% power and 147 per arm for 90% power; for 50%, the corresponding figures are 247 and 330 per arm. Smaller target effects require more participants because they are harder to distinguish from random variation.

The figures are not evidence that the trial had a particular probability of finding a statistically significant result. This is not observed power. They are prospective illustrations calculated from the observed effect and stated assumptions, and their values should not be mistaken for the trial's original recruitment target or a justification reported by its investigators.

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 = -2.600; pooled standard deviation σ = 5.150.
2. n = 2 × (1.96 + 0.842)² × 5.150² / -2.600² = 61.6, rounded up to 62 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 <- -2.6                      # observed difference in means
sigma <- 5.15024271272724                     # 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(5050227)
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 = 62 (80% power), 83 (90% power)
 75% of observed effect: n per arm = 110 (80% power), 147 (90% power)
 50% of observed effect: n per arm = 247 (80% power), 330 (90% power)
power.t.test: 62.6 
Simulated power at n = 62 per arm: 0.794 (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 primary and secondary outcomes create a multiple-comparison setting. When several hypotheses are examined, the chance of at least one apparently unusual result can rise even if none of the underlying effects is real. Statistical approaches can account for multiplicity by defining a testing hierarchy or adjusting error rates. The registry record does not report whether such an approach was planned or used. The posted p-values are unadjusted, so secondary results should be interpreted cautiously rather than as confirmatory evidence.

The record lists outcomes in addition to the posted PHQ-9, GAD-7, PAM, and PCL-5 results. It does not report analyses for every outcome listed, and does not explain the absence of those results. This leaves uncertainty about the complete set of analyses conducted and whether outcome reporting followed a prespecified plan. The record does not report a protocol-level distinction between confirmatory and exploratory outcomes.

Missing-data handling is also not reported. The primary endpoint summaries include 21 participants per arm, while overall enrollment is 57. The registry does not explain the difference between those figures, identify reasons for unavailable endpoint observations, or describe imputation, weighting, or complete-case procedures. It is therefore not possible to determine from the record whether missingness affected the estimates or whether the analysis relied only on participants with observed scores.

The analysis population is not specified. The record does not state whether the primary comparison followed an intention-to-treat principle, included participants according to treatment received, or used another population definition. It also does not report a per-protocol analysis or sensitivity analyses addressing departures from the assigned intervention.

These omissions do not establish that the study failed to conduct such procedures; they mean the registry record does not report them. They limit independent assessment of the analysis choices and the degree to which the posted findings reflect a prespecified plan.

15. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports serious adverse events for 29 participants at risk in cCBT Enhanced Collaborative Care and 28 in Usual Care. It reports zero serious adverse events affecting participants in either group. Deaths are also reported as zero in both groups. The posted other-adverse-event figures likewise report zero events affecting participants in each arm, with 29 and 28 participants at risk, respectively.

These figures describe what was recorded in the registry for the stated groups and risk sets. They do not establish that no adverse events of any kind occurred beyond what was reported, and they do not estimate comparative safety with high precision. The efficacy endpoint summaries report 21 participants per arm, whereas the safety risk sets are different; the registry does not explain the relationship between these denominators.

The record does not provide serious-event terms, and it does not report further detail about event definitions, ascertainment, follow-up completeness, or a formal comparison between arms. The absence of reported serious events should therefore be read as a registry summary, not as proof that the intervention has no risks.

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

The posted primary result describes a lower mean PHQ-9 score at 3-months in cCBT Enhanced Collaborative Care than in Usual Care. The estimated mean difference is negative, and the confidence interval extends across zero. This is evidence of a numerical difference in the observed summaries alongside uncertainty about the size and direction of the underlying group contrast.

The result does not establish that the intervention caused the observed difference. Random allocation is part of the design, but the registry record does not report enough analysis detail to evaluate the original model, missing-data handling, analysis population, or adherence to a prespecified plan. The posted comparison is unadjusted and based on the reported summary statistics.

The result also does not show that every participant's symptoms changed in the same direction. Group means can conceal individual variation, and the registry does not report individual trajectories or a responder analysis. The outcome is measured at 3-months; it does not establish persistence beyond that time point. The record does not report a threshold defining a clinically important score difference, so clinical importance cannot be inferred solely from the mean contrast.

The pilot study's scope matters. Its findings describe the reported participants and setting, not all people with depression or all primary care systems. The registry's stated aim was to adapt and pilot test collaborative care models to improve uptake of computerized cognitive behavioral therapy, but the posted primary endpoint is symptom score. The result therefore does not itself establish increased uptake, implementation success, or the feasibility of broader delivery.

A balanced reading is that the intervention arm had a lower observed average depression symptom score at follow-up, with an interval and unadjusted test that leave uncertainty about the difference. The posted statistics are useful for describing this pilot and planning future research; they do not support a definitive claim about benefit, lack of benefit, clinical importance, or safety.

17. Why This Trial Matters Statistically

This trial illustrates why a group mean, an uncertainty interval, and a p-value should be considered together. The point estimate communicates the direction and scale of the observed contrast, while the confidence interval makes clear that the estimate is not precise enough to exclude no difference. A p-value alone would not communicate that range or the potential importance of values within it.

The study also demonstrates the distinction between a pilot result and a definitive comparison. The endpoint groups were modest in size, and the posted planning illustrations show that detecting smaller target effects requires larger groups under the stated assumptions. Those illustrations are not the original design rationale, but they make the relationship between effect size, sample size, and precision concrete.

Outcome multiplicity is another important statistical issue. Several measures cover related aspects of health, but unadjusted secondary comparisons do not provide the same evidential weight as a primary, prespecified analysis. Without a reported hierarchy or multiplicity plan, a common direction across estimates can be informative descriptively while remaining insufficient for confirmatory conclusions.

Finally, the difference between overall enrollment and endpoint counts, along with the absence of reported missing-data and analysis-population details, highlights the value of complete registry reporting. Such details help readers understand who contributed to each estimate and how uncertainty was handled. The trial is statistically useful as an example of interpreting pilot outcomes cautiously, separating planning scenarios from observed evidence, and treating precision as central to the meaning of a result.

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 offers limited detail about the trial's methods beyond randomization, single masking, and parallel allocation. It does not report how randomization was generated or concealed, which parties were masked, or how usual care was defined. Those details would help readers assess the design and potential for bias.

For the primary outcome, the record gives endpoint summaries but not baseline PHQ-9 scores or change-from-baseline estimates. It does not report an adjusted analysis, a defined analysis population, missing-data procedures, or sensitivity analyses. Endpoint group counts and overall enrollment are reported, but the record does not explain their relationship.

The original sample-size justification and analysis plan are not reported. The planning illustrations calculated from observed effects do not fill that gap and should not be interpreted as the design rationale. The record also does not report whether secondary outcomes were prespecified as confirmatory, or whether multiplicity was addressed. Some outcomes listed in the record do not have posted analyses, and the reason is not reported.

The main endpoint is a symptom scale at 3-months. The record does not report a threshold for clinical importance, a responder outcome, or later follow-up results. Therefore, the posted summaries do not establish individual-level improvement, durability, or the practical importance of the group mean difference. Because this is a pilot in a VA primary care context, results should not automatically be generalized to other populations or care settings.

Safety summaries report no serious events, other adverse events, or deaths affecting participants, but further ascertainment and event-definition details are not reported. These limitations concern what can be evaluated from the registry record; they do not establish that unreported procedures or analyses were not conducted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Improving Depression Management — NCT05050227.
• Registry record last updated 2025-07-20; status last verified 2025-07.
• Results first posted 2024-09-19.
• 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

NCT05050227, titled Improving Depression Management, is a completed randomized, single-masked, parallel-group study sponsored by the VA Office of Research and Development. It enrolled 57 participants and compared cCBT Enhanced Collaborative Care with Usual Care in the context of depression management in VA primary care.

The primary endpoint was mean PHQ-9 score at 3-months. The posted mean was 12.6 in the intervention arm and 15.2 in Usual Care, with a mean difference of -2.6 and an unadjusted p-value of 0.102. The confidence interval extends across zero, indicating uncertainty about the contrast. Posted secondary comparisons are also imprecise and unadjusted.

The registry reports zero serious adverse events and deaths in both groups. Details on the original sample-size rationale, missing-data handling, analysis population, multiplicity procedures, and several other analysis choices are not reported in the registry record.