A Teleheath tDCS Approach to Decrease Cannabis Use: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Teleheath tDCS Approach to Decrease Cannabis Use (NCT05005013), a randomized phase 2 study. The primary outcome is Change in Kessler Psychological Distress Scale (K10) Score.

2. Clinical Question

3. Trial Design

The registry describes a Phase 2, randomized, double-masked, parallel-group study. The two groups are Active tDCS + Mindfulness and Sham tDCS + Mindfulness. Both groups therefore include mindfulness, while the stimulation condition differs. The registry lists the study as completed, with enrollment of 52. The brief summary describes a recruitment target of 46 participants, so the record contains both an enrollment figure and a different target in its summary; it does not explain the relationship between them.

The study addresses Cannabis Use Disorder and Multiple Sclerosis. Its summary specifies relapse remitting multiple sclerosis and elevated distress, described as a K10 score of 10-35. The intervention description identifies dorsolateral prefrontal cortex transcranial direct current stimulation as the active treatment component. The available arm descriptions do not provide additional detail about how stimulation or mindfulness was delivered.

The primary outcome is change in K10 score, measured from baseline to the end of intervention at Week 4. The registry also identifies secondary outcomes concerning distress, positive and negative affect, craving, withdrawal, and weekly and monthly cannabis-use sessions. Follow-up timeframes for posted secondary results include the end of intervention at Week 4 and Month 3. The record does not report the randomization procedure, masking procedures, allocation concealment, study sites, or detailed visit schedule. These details should not be inferred from the general design labels.

The primary outcome results are posted for 22 participants in the active group and 13 in the sham group. Those group counts describe the posted endpoint data; the record does not explain why they differ from the enrollment figure, whether all enrolled participants were randomized, or how missing outcome data were handled. The registry lists 14 outcome measures and no reported analyses. Consequently, the posted descriptive summaries and unadjusted comparisons should be distinguished from a fully described statistical analysis plan.

4. Participant Flow and Accounting

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

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as Change in Kessler Psychological Distress Scale (K10) Score, measured over Baseline, End of Intervention (Week 4).

The primary endpoint is change in Kessler Psychological Distress Scale score, or K10 score, from baseline to the end of intervention at Week 4. K10 is a 10-item questionnaire intended to measure global psychological distress through questions about anxiety and depressive symptoms experienced during the most recent 4 week period. Each item is scored from 1, none of the time, to 5, all of the time; the total ranges from 10 to 50.

The registry description gives score bands intended to characterize distress: scores < 20 are likely to indicate that a person is well, 20-24 are likely to indicate a mild mental disorder, 25-29 a moderate mental disorder, and scores > 30 a severe mental disorder. These descriptions provide context for what the measure is designed to capture, but they do not replace the trial’s group comparison. The posted primary result concerns mean change, not the number of participants crossing any one of these score thresholds.

A continuous score can retain information about changes across its range, rather than reducing each participant to a category. The mean summarizes the group’s average change, while the standard deviation describes variation in individual changes around that average. The endpoint is relevant to the study’s stated aim of evaluating distress. The registry record does not report a rationale for selecting K10 as the primary measure, a clinically important difference, or a prespecified interpretation threshold for change.

7. Results Posted in the Registry

• Active tDCS + Mindfulness: mean 6.40 versus 4.50 on control; difference 1.90 (95% CI -1.52 to 5.32), standardized effect d = 0.35; z-test p = 0.276.

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 in Kessler Psychological Distress Scale (K10) Score

• 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:
  • Active tDCS + Mindfulness: mean 0.30 versus 1.33 on control; difference -1.03 (95% CI -3.99 to 1.93), standardized effect d = -0.24; z-test p = 0.495.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active tDCS + Mindfulness and the control. The interval gives the range of effects that remain compatible with the data.

Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)

• 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:
  • Active tDCS + Mindfulness: mean -1.20 versus -0.60 on control; difference -0.60 (95% CI -4.50 to 3.30), standardized effect d = -0.10; z-test p = 0.763.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active tDCS + Mindfulness and the control. The interval gives the range of effects that remain compatible with the data.

Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)

• 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:
  • Active tDCS + Mindfulness: mean 2.60 versus 1.00 on control; difference 1.60 (95% CI -2.14 to 5.34), standardized effect d = 0.27; z-test p = 0.402.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active tDCS + Mindfulness and the control. The interval gives the range of effects that remain compatible with the data.

The registry identifies secondary measures covering distress, positive and negative affect, marijuana craving, cannabis withdrawal, and the number of weekly and monthly cannabis-use sessions. The posted secondary results also include K10 and positive and negative affect changes over a timeframe that includes the end of intervention at Week 4 and Month 3. Across the available secondary comparisons, the confidence intervals include zero and the unadjusted p-values are not small. Collectively, these results do not provide a clear, precise pattern of between-group differences in the posted summaries.

The secondary outcomes broaden the questions beyond the primary K10 comparison: some concern psychological experiences, while others address craving, withdrawal, and reported cannabis-use frequency. They can help describe whether the groups showed similar or different patterns across related domains, but each endpoint has its own measurement properties and uncertainty. The secondary findings do not replace the primary endpoint result, and they do not establish that changes in distress correspond to changes in cannabis use.

The registry lists 14 outcome measures and reports no analyses. The record does not state whether the secondary outcomes were designated in advance, how their timepoints were selected for analysis, or whether inferential testing was adjusted for examining multiple outcomes. General statistical principle: testing many outcomes increases the opportunity for apparently notable findings to arise by chance. Unadjusted secondary results therefore carry less weight than a prespecified primary comparison, particularly when the analysis plan and multiplicity handling are not reported.

The registry record does not report numerical results for every secondary outcome named in the outcome list. Without complete results and an analysis description, the secondary outcomes should be read as additional descriptive evidence rather than as a comprehensive, confirmatory assessment of every study aim.

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

• Change in Kessler Psychological Distress Scale (K10) Score
• Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
• Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
• Change in Marijuana Craving Questionnaire (MCQ-17) Score
• Change in Cannabis Withdrawal Scale (CWS) Score
• Change in Number of Weekly Sessions of Cannabis Use
• Change in Number of Monthly Sessions of Cannabis Use

9. Statistical Interpretation

10. Statistical Methods Explained

The posted primary outcome is continuous: each participant has a K10 change score, and the results are expressed as group means and standard deviations. A mean is the arithmetic average of the scores in a group. A standard deviation describes how spread out those scores are around the mean. It is not the uncertainty in the mean itself; uncertainty in a mean comparison is reflected more directly by the confidence interval.

What does the mean difference represent?

The comparison is oriented as Active tDCS + Mindfulness minus Sham tDCS + Mindfulness. The active group mean is 6.4, and the sham group mean is 4.5, yielding the posted mean difference of 1.9. A positive value therefore means that the active group’s reported mean change is numerically higher under this subtraction order. The registry record does not specify the coding convention for change or give a clinical interpretation of a positive change score, so the direction should not be translated into improvement or worsening without that context.

The comparison is between two randomized groups, and both groups received mindfulness. It therefore describes the difference associated with assignment to active versus sham stimulation within this study’s mindfulness context. It does not estimate the effect of mindfulness itself, because there is no mindfulness-free group in the posted design.

What does the p-value say?

The unadjusted p-value is 0.276. In general, a p-value measures how incompatible the observed data are with a specified null model, assuming that model and the calculation’s assumptions hold. A larger p-value does not prove there is no difference, and it is not the probability that the null hypothesis is true. The registry record does not describe a multiplicity adjustment or a complete inferential plan, so this value is best treated as an unadjusted result for the posted comparison.

Why does variability matter?

The primary group standard deviations are 6.1 and 4.2. General statistical principle: greater variability makes a group mean less precisely estimated when sample size is unchanged, and tends to widen uncertainty around a comparison. The endpoint counts are modest and unequal, so the estimate depends on a relatively small set of observed scores. The record does not report the individual-level data or distributional checks, which prevents assessment of whether the change scores were symmetric, contained influential observations, or met assumptions of a particular model.

The comparison summary includes an unadjusted mean difference and confidence interval. It does not describe a regression model, covariate adjustment, stratification, or a repeated-measures model. The record lists baseline and Week 4 as the primary timeframe, but it does not say whether the posted change analysis used the raw change scores, a baseline-adjusted model, or another approach. Those analytic details are not reported in the registry record.

What is the role of a confidence interval?

In general, a confidence interval is a range generated by a statistical procedure that, under its assumptions and repeated use, captures the underlying parameter at a stated rate. For a single trial, it is useful as a range of values reasonably compatible with the data and method. The interval from -1.522 to 5.322 includes zero and spans values on both sides of zero. It therefore communicates uncertainty that cannot be conveyed by the point estimate alone. It is not a guarantee that the true difference lies within this particular interval.

The record does not report the exact interval construction method, whether the comparison used a pooled or unequal-variance approach, or whether any adjustment was made. The displayed standard deviations are descriptive summaries; they do not establish which inferential method generated the interval or p-value. Those choices should not be reverse-engineered from the numbers.

What is not specified?

The registry lists no reported analyses. It does not report a formal statistical analysis plan, the original sample-size justification, the planned significance level for the primary analysis, interim analyses, analysis populations, covariates, missing-data methods, or multiplicity procedures. General methods explanations can clarify what means, standard deviations, p-values, and intervals represent, but they cannot fill these protocol-level gaps. The planning illustrations have their own stated assumptions and should not be mistaken for the trial’s original design assumptions.

11. Confidence Intervals and Precision

The primary mean difference is 1.9 score points, with a 95% confidence interval from -1.522 to 5.322. The interval includes zero and covers both negative and positive differences. This means the observed point estimate alone does not convey the full uncertainty: the data are compatible with a range that includes no mean difference and also includes nonzero differences in either direction.

The interval is relatively broad in relation to the point estimate, so the registry results do not pinpoint the size or direction of the group difference precisely. The group standard deviations are 6.1 for active tDCS plus mindfulness and 4.2 for sham tDCS plus mindfulness, while the endpoint counts are 22 and 13, respectively. General statistical principle: uncertainty in a group comparison depends on both variability and the amount of information available. A limited number of observations and variation among participants can leave a wide range of plausible values.

The confidence interval describes uncertainty under the method used to calculate it. The registry record does not report the interval method or a full analysis plan, so it is not possible to assess all of the assumptions behind the interval from the record alone. The posted interval also does not measure uncertainty about other endpoints, long-term outcomes, or the generalizability of the result to populations outside those studied.

The interval should not be interpreted as demonstrating equivalence or as proving that clinically meaningful differences are absent. The registry record does not state an equivalence margin or a clinically important difference for K10 change. Precision is therefore best described in terms of the range of statistical values compatible with the posted comparison, not a clinical 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. They are illustrations based on the observed effect and use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustrated effect to detect is a stated fraction of the observed effect: 100%, 75%, or 50%. These are planning assumptions for the illustrations; the registry record does not report the original trial’s sample-size assumptions or justification.

The 80% power column represents the number of participants per arm estimated to give an 80% chance of detecting the specified effect under the stated planning assumptions, if that effect is the true one and the assumptions hold. The 90% power column uses a higher target chance of detection, so its participant requirements are larger for the corresponding effect. Power is a design property under a specified effect and statistical model; it is not a guarantee that a study will produce a statistically significant result.

For example, the primary-outcome illustration for 100% of the observed effect lists 131 participants per arm for 80% power and 176 participants per arm for 90% power. At 75% of the observed effect, the corresponding figures are 233 and 312 participants per arm; at 50%, they are 524 and 701. These examples show the general pattern: a smaller effect is harder to distinguish from random variation and therefore requires more participants under the same assumptions.

The figures are not observed power and do not indicate the probability that the trial’s result is correct. They are retrospective planning illustrations derived from the observed effect, which may itself be uncertain. They should not be treated as evidence that the original study was designed around these participant counts or assumptions. The registry record does not report that original design information.

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 = 1.900; pooled standard deviation σ = 5.486.
2. n = 2 × (1.96 + 0.842)² × 5.486² / 1.900² = 130.9, rounded up to 131 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.9                      # observed difference in means
sigma <- 5.48576670700061                     # 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(5005013)
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 = 131 (80% power), 176 (90% power)
 75% of observed effect: n per arm = 233 (80% power), 312 (90% power)
 50% of observed effect: n per arm = 524 (80% power), 701 (90% power)
power.t.test: 131.8 
Simulated power at n = 131 per arm: 0.796 (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 14 outcome measures, including a primary K10 change outcome and secondary measures addressing distress, affect, craving, withdrawal, and cannabis-use frequency. It reports no analyses. The record does not describe a formal statistical analysis plan, a hierarchy of hypotheses, or procedures for controlling the chance of false-positive findings across multiple endpoints or timepoints.

Multiplicity is a general concern when a study evaluates many outcomes. If each is tested separately without adjustment, the chance of at least one result appearing noteworthy by chance can increase. This does not make every unadjusted result invalid, but it affects how strongly secondary findings should be interpreted. The primary outcome is the clearest designated endpoint in the registry, while secondary comparisons are better treated as exploratory unless a prespecified confirmatory strategy is documented. Such a strategy is not reported in the registry record.

Missing-data handling is also not reported. The primary results include 22 participants in the active group and 13 in the sham group, while total enrollment is listed as 52. The record does not say how many participants were randomized, whether all randomized participants were included in the primary analysis, why the outcome counts differ from enrollment, or whether missing scores were imputed or analyzed by another method. It also does not report a sensitivity analysis for missing outcomes.

Analysis populations are not described. In particular, the registry does not identify an intention-to-treat population, a per-protocol population, or the rules used to determine inclusion in the posted comparisons. This limits assessment of whether the estimates reflect group assignment for all randomized participants or only those with available endpoint measurements. Interim analyses, stopping rules, and prespecified covariate adjustments are likewise not reported in the registry record. These gaps do not establish that such procedures were absent; they mean the posted record does not document them.

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.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events among 22 participants at risk in the Active tDCS + Mindfulness group and zero among 13 participants at risk in the Sham tDCS + Mindfulness group. It lists zero deaths in both groups. For other adverse events, the record reports zero among 22 at risk in the active group and one among 13 at risk in the sham group.

These are the counts posted in the registry and should be read as event reporting for the recorded groups, not as a complete comparison of safety. The record does not provide the nature of the one other adverse event, its timing, severity, or whether it was considered related to study treatment. It also does not report definitions, ascertainment procedures, or follow-up completeness for adverse events. The absence of reported serious events in these group counts does not establish that no other harms occurred or that the interventions are free of risk.

With the posted counts and limited detail, no precise comparative safety estimate is available. The record’s safety information is descriptive and should be interpreted alongside its small group counts and the limits of event reporting.

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

The posted primary outcome comparison describes mean K10 change between participants assigned to active tDCS plus mindfulness and participants assigned to sham tDCS plus mindfulness. The estimated mean difference is 1.9 score points, and the 95% confidence interval ranges from -1.522 to 5.322. The interval includes zero, and the unadjusted p-value is 0.276. These results do not provide a precise estimate of the difference between groups.

The result does not show that active stimulation caused a change in distress, nor does it establish that the groups were equivalent. The record does not report a clinical importance threshold for K10 change, and the direction of score change is not explicitly interpreted in the outcome description. The score’s general bands describe K10 levels, but the primary result is a comparison of mean change rather than a comparison of how many participants moved between score categories.

The design compares active with sham tDCS while mindfulness is present in both groups. It therefore does not isolate the effect of mindfulness, and it does not directly test mindfulness against no mindfulness. The registry’s stated study aims also include cannabis use, but the primary endpoint is distress. K10 findings alone cannot establish an effect on craving, withdrawal, cannabis-use sessions, or multiple sclerosis disability.

The available results apply to the measures, participants, and follow-up periods recorded in this study. The registry describes people with relapse remitting multiple sclerosis, cannabis use disorder, and elevated distress, but does not provide enough detail to determine how representative the participants are of other populations. The difference between listed enrollment and primary endpoint group counts is not explained, and analysis populations and missing-data methods are not reported.

Overall, the posted figures are compatible with a range of possible mean differences. They support a cautious statistical description, not a clinical recommendation. Additional information about the analysis plan, completeness of follow-up, and outcomes beyond the primary K10 measure would be needed to assess broader claims.

17. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a randomized design and a continuous patient-reported endpoint can be summarized. Randomization aims to create comparable groups on average, while the sham condition offers a comparison for active stimulation; mindfulness is included in both arms. The posted results allow readers to inspect group means, variability, a mean difference, and its confidence interval rather than relying on a single significance judgment.

The confidence interval is especially important because the point estimate alone could invite an overly definite interpretation. The interval extends from -1.522 to 5.322 and includes zero, showing that uncertainty remains about both the direction and size of the difference. The relatively small endpoint counts, 22 and 13, make precision an important consideration. The result illustrates why a nonsignificant p-value is not proof of no difference and why an interval should be read alongside the estimate.

The registry also shows why transparent analysis reporting matters. It lists 14 outcome measures but no analyses, and does not describe multiplicity handling, missing-data methods, analysis populations, or the original sample-size justification. Without these details, readers cannot fully evaluate whether the posted comparisons were prespecified, how incomplete outcome data were treated, or how much confirmatory weight to assign to secondary outcomes.

Finally, the planning illustrations make the relationship between effect size and sample requirements concrete: smaller effects require larger studies under the stated assumptions. Those illustrations do not explain the original design, but they emphasize that precision depends on study scale as well as measurement variability. The trial’s statistical value lies in the estimates and uncertainty it reports, while the limitations in documentation define how far those estimates can be interpreted.

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.

Several limitations specific to this record constrain interpretation. The primary outcome counts are 22 participants in the active group and 13 in the sham group, while enrollment is listed as 52 and the brief summary describes a recruitment target of 46. The registry record does not explain the relationship among those figures or the reasons that fewer participants appear in the primary endpoint summaries. It does not report how missing observations were handled or identify the analysis population.

The record reports a mean change comparison but does not describe the statistical model, interval construction, or whether baseline values or other covariates were included. It also does not give individual-level results or distributional checks, so the influence of unusual scores and the suitability of particular assumptions cannot be assessed. A formal analysis plan and multiplicity procedure are not reported despite the listing of multiple outcomes.

Intervention details are limited. The registry identifies active and sham tDCS and mindfulness but does not provide the stimulation parameters, full sham procedure, mindfulness content, or adherence information. The double-masked designation is reported, but the record does not explain who was masked or how masking was maintained.

The primary outcome is measured through Week 4. The available secondary timeframes include Month 3, but the registry does not report longer-term follow-up in the primary outcome description. The record also does not provide a clinical importance threshold for K10 change, making it difficult to judge the practical meaning of the estimated score difference. These limitations reflect what is not documented in the registry and do not establish that the procedures or assessments were not conducted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Teleheath tDCS Approach to Decrease Cannabis Use — NCT05005013.
• Registry record last updated 2025-06-24; status last verified 2025-06.
• Results first posted 2025-06-24.
• 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 Phase 2, randomized, double-masked, parallel-group study of active versus sham tDCS, with mindfulness in both groups, among people with multiple sclerosis and cannabis use disorder. Enrollment is listed as 52; the study summary describes a target of 46 participants with relapse remitting multiple sclerosis, cannabis use disorder, and elevated distress.

The primary outcome is change in K10 score from baseline to the end of intervention at Week 4. The posted mean difference was 1.9, with a 95% confidence interval from -1.522 to 5.322 and an unadjusted p-value of 0.276. Primary endpoint counts were 22 in the active group and 13 in the sham group. The registry lists 14 outcome measures and no reported analyses. Its record does not explain the enrollment-to-outcome-count relationship, analysis populations, missing-data methods, or multiplicity procedures.