RCT of CBD for Anxiety in Advanced Breast Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for RCT of CBD for Anxiety in Advanced Breast Cancer (NCT04482244), a randomized phase 2 study. The primary outcome is Change in Anxiety Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale.

2. Clinical Question

The clinical question is narrowly focused on short-term anxiety scores around a planned scan. It is not a question about longer-term anxiety, cancer outcomes, or the effect of repeated dosing. The primary measure is a reported mood score, not a direct assessment of imaging outcomes. The registry also lists secondary measures, including adverse events, mood, nausea, and pain, but those measures do not change the primary comparison being asked.

3. Trial Design

This is a randomized, double-blind, parallel-group Phase II study sponsored by Dana-Farber Cancer Institute. Its official title describes a single dose of cannabidiol for acute anticipatory anxiety in advanced breast cancer. The registry lists an enrollment of 60. That enrollment field should not be read as the number included in the posted primary analysis: the outcome summaries report 25 participants in each treatment group, and the final number enrolled or analyzed is not reported in the registry record.

After screening, participants were assigned to cannabidiol or placebo. Both groups completed questionnaires and received one dose before a diagnostic CT or PET scan. The parallel design means the two groups were compared with one another rather than having each participant receive both study conditions. The double-blind designation indicates masking was part of the design, but who was masked, how the placebo was matched, and whether masking was assessed are not reported in the registry record.

The registry lists the study start as 2022-01-19 and primary completion as 2023-03-01. Its current status is active, not recruiting. These registry fields do not establish that all study follow-up or reporting is complete. The posted primary result gives group means and standard deviations for the change score, along with an unadjusted comparison. It does not report the analysis population definition, participant flow, reasons for missing outcome data, or a detailed statistical analysis plan. Those omissions limit how fully the posted group summaries can be connected to the trial’s original conduct and analysis.

The comparison is between the mean change in anxiety score in the cannabidiol group and the mean change in the placebo group. The reported contrast is an unadjusted mean difference. No covariate-adjusted result or subgroup analysis is reported in the registry record. The design and results therefore support a focused reading of the posted comparison, not broader conclusions about other settings, dosing schedules, or outcomes.

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: 501 screened. 310 excluded: 76 on clinical drug trial, 64 not responding, 37 declined,133 excluded for other reasons. Of 191 meeting eligibility, 54 without scheduled scan, 40 had scan too soon, 27 denied anxiety, \& 3 excluded for other reasons. 67 scheduled for consent: 3 lost interest, 3 denied anxiety, \& 1 did not attend. 60 patients consented, but 10 were not randomized, because they didn't meet eligibility criteria. 50 total participants were eligible, consented and randomized.

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 Change in Anxiety Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale, measured over 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day.

The primary endpoint is change in the Visual Analog Mood Scale (VAMS) Anxiety Subscale, reported as a T-score. The registry’s description refers to the “Afraid” negative-mood subscale. Participants mark their current mood on a horizontal scale anchored by a neutral face and a face representing extreme endorsement. The distance from the neutral face produces a raw score, which is converted to a T-score using a manual table based on sex and age bracket.

The endpoint is designed to capture a participant’s reported mood at the time of assessment. Measuring before dosing and again after dosing allows the study to summarize within-person change over that short interval, then compare average changes between randomized groups. The registry defines the change score as the post-dose T-score minus the pre-dose T-score. A negative change therefore represents a lower post-dose score than pre-dose score; it should be interpreted as a change in this measured subscale, not by itself as evidence about other aspects of anxiety or well-being.

The registry describes a 20T-score (+/-) difference between pre- and posttest scores as a reliable change in mood, and a difference of more than 30T-score (+/-) as both reliable and clinically significant under its stated interpretation. Those thresholds describe individual score changes; they are not the same as the estimated difference between group means. The endpoint is relevant to an acute pre-scan question because it is assessed around the time of dosing and imaging. Its interpretation remains specific to the VAMS measure and the stated assessment window.

7. Results Posted in the Registry

• Cannabidiol: mean -19.10 versus -15.00 on control; difference -4.10 (95% CI -11.50 to 3.30), standardized effect d = -0.31; z-test p = 0.277.

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.

Numeric Pain Rating Scale (NPRS)

• 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:
  • Cannabidiol: mean -0.88 versus -0.88 on control; difference 0.00 (95% CI -0.77 to 0.77), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cannabidiol and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary measures spanning treatment-related adverse events, mood, nausea, and pain. Their roles differ: some describe safety or tolerability, while others provide additional patient-reported outcomes. They complement the primary anxiety measure by broadening the set of observations around the dosing and imaging period, but they do not replace the primary endpoint or answer the same question.

The quantitative secondary result available in the registry record is for the Numeric Pain Rating Scale. The registry also names other secondary outcomes, including a mood measure and nausea, but their numerical results are not reported in the record summarized for this trial. Consequently, an overall pattern across all secondary endpoints cannot be established from the available results. The absence of a numerical result is not evidence that no change occurred.

Secondary endpoints can help describe whether observations are consistent across different measures, but multiple outcomes create more opportunities for apparently notable findings by chance. An unadjusted result does not account for the number of outcomes examined. Unless the analysis plan specifies how multiplicity is handled, isolated secondary findings generally carry less weight than a prespecified primary result and should be treated as exploratory. The multiplicity approach is not reported in the registry record.

The primary comparison remains the most direct posted test of the trial’s stated central question: acute change in anxiety score after one dose before imaging. Secondary findings may add context, but they should not be combined into a single conclusion or treated as interchangeable outcomes. The incomplete numerical reporting across the secondary measures also limits any claim about whether the primary pattern was accompanied by a consistent pattern in other domains.

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

• Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
• Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
• Nausea Rate
• Numeric Pain Rating Scale (NPRS)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a numerical change score, and the registry reports a group mean and standard deviation. For each arm, the mean summarizes the average change, while the standard deviation describes how spread out individual scores are around that average. A standard deviation is not the uncertainty in the mean itself. The uncertainty in a group mean also depends on the number of observations and on the variability of scores.

What does the mean difference represent?

The posted contrast is the cannabidiol mean minus the placebo mean. It compares the groups’ average change scores, rather than comparing the two group means as if they were scores at a single time point. A negative contrast means the average change was more negative in the cannabidiol group under that subtraction order. This arithmetic direction is descriptive; it does not on its own say whether the difference is important or reliably attributable to the assigned group.

The outcome definition makes the direction of change explicit: post-dose T-score minus pre-dose T-score. The analysis thus concerns change over the assessment interval. The registry does not report whether the analysis used a particular model, any adjustment for baseline score, or how deviations from the planned assessment times were handled. Those details should not be inferred from the reported means.

How should the interval and p-value be read?

A confidence interval expresses uncertainty around an estimated quantity by giving a range of values compatible with the data and the method used. In general, a wider interval indicates less precision than a narrower interval. For this result, the posted interval extends from -11.5 to 3.296 T-score. Because it includes values on both sides of no mean difference, the data summarized by that interval are compatible with a range of directions for the group contrast. The confidence level and the method used to construct the interval are not reported in the registry record.

The p-value is reported as unadjusted and equals 0.277. In general, a p-value describes how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the test assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The registry does not identify the test or its assumptions, so the p-value should be read as the posted unadjusted statistic rather than as evidence about an undocumented analysis procedure.

What do the reported group sizes and variation tell us?

The primary summaries include 25 participants per arm. The standard deviations are 15.4 for cannabidiol and 10.9 for placebo. These values describe observed variation in change scores in the posted groups. They help explain why a group mean is only an estimate of the average change that might be seen in a broader population: participants can have quite different score changes, and a mean compresses those differences into one summary.

The registry also gives a pooled standard deviation of 13.34 for the comparison. A pooled standard deviation is a combined estimate of within-group variability used in some two-group summaries. Its presence does not identify the test used for the primary result, and it does not turn the comparison into an adjusted analysis. The standardized effect size is not needed to interpret the reported mean difference in its original T-score units.

What is not established by the posted analysis?

The registry record does not report an analysis plan, a model specification, the confidence level, a missing-data method, an intention-to-treat definition, or a per-protocol definition. It also does not report whether any interim analyses occurred. These are important analysis details, particularly when a trial includes more than one outcome, but their absence does not mean a particular method was or was not used. It means the method cannot be verified from the registry record.

Randomization is intended, in general, to create groups that are comparable on average at assignment. It does not guarantee that every characteristic is balanced in a particular trial, nor does it resolve missing data or measurement problems. The registry’s aggregate summaries do not show baseline comparability, individual trajectories, or reasons for missing measurements. As a result, interpretation should remain anchored to the posted unadjusted group summaries and the limitations of the recorded analysis details.

11. Confidence Intervals and Precision

The primary estimate is a mean difference of -4.1 T-score, with a posted interval from -11.5 to 3.296. The interval is appreciably broad relative to the point estimate and includes both negative and positive differences. In practical terms, the estimate does not pin down a single direction or narrow range for the average group contrast. Its endpoints should be read as uncertainty around the estimated difference, not as the lowest and highest changes experienced by individual participants.

A confidence interval is useful because it conveys more than a point estimate. General statistical interpretation is that a narrow interval gives a more precise estimate, while a wide interval leaves more uncertainty about the size and possibly the direction of the effect. The posted interval includes no mean difference, but that fact does not demonstrate equivalence. Equivalence requires a prespecified margin and an analysis designed to assess whether the plausible differences are confined within that margin; such a margin is not reported in the registry record.

The confidence level and interval-construction method are not reported in the registry record. The interval can therefore be quoted as posted, but its exact inferential calibration cannot be assessed from the record alone. The unadjusted p-value of 0.277 also does not replace the interval: the p-value provides a test statistic in relation to a null hypothesis, whereas the interval displays a range of effect sizes consistent with the estimate and its uncertainty under an interval method.

The endpoint’s individual-change thresholds are not a substitute for precision around a between-group mean. A group-level interval does not reveal how many participants met either threshold. Nor does the mean difference communicate the full spread of participant responses. The group standard deviations indicate that individual changes varied, but the registry record does not provide a distribution or threshold-based summary for those individual changes.

12. Planning a Similar Trial: Sample Size

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

The sample-size table and curve are planning illustrations based on the observed effect, not a reconstruction of the trial’s original design. The figures are participants per arm, not total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the planned number of participants per arm under the stated assumptions for a design with an 80% chance of detecting the specified effect if that effect is the true one and the assumptions hold. The 90% power column uses a higher chance of detection, so it requires more participants per arm under the same effect assumptions. These are design-planning quantities, not descriptions of what happened in the trial. This is not observed power.

The rows consider planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. For 80% power, the corresponding figures are 167, 296, and 665 participants per arm. For 90% power, the corresponding figures are 223, 396, and 891 participants per arm. A smaller effect is harder to distinguish from random variation, so planning to detect a smaller effect requires more participants under these assumptions.

These illustrations use the observed effect as their starting point, which is uncertain in a trial of this size. They should not be interpreted as a recommendation, a guarantee of precision, or evidence about the study’s original target. The planning figures also depend on the stated normal approximation and equal allocation; different planning assumptions could yield different sample-size estimates.

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 = -4.100; pooled standard deviation σ = 13.341.
2. n = 2 × (1.96 + 0.842)² × 13.341² / -4.100² = 166.2, rounded up to 167 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 <- -4.1                      # observed difference in means
sigma <- 13.3411019035161                     # 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(4482244)
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 = 167 (80% power), 223 (90% power)
 75% of observed effect: n per arm = 296 (80% power), 396 (90% power)
 50% of observed effect: n per arm = 665 (80% power), 891 (90% power)
power.t.test: 167.2 
Simulated power at n = 167 per arm: 0.798 (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 identifies one primary outcome and lists several secondary outcomes. Examining multiple outcomes can increase the chance that at least one result appears unusual even when there is no underlying effect for that outcome. General statistical practice may address this issue through a prespecified testing hierarchy, an adjustment for multiple comparisons, or an explicitly exploratory interpretation. The registry record does not report a multiplicity procedure, a testing hierarchy, or which outcomes were designated for formal hypothesis testing.

The primary p-value is labeled unadjusted. The posted secondary result is also not accompanied by a reported multiplicity adjustment. Unadjusted values answer a narrower question than adjusted family-wide inference: they do not account for the possibility that multiple outcomes were examined. This is why secondary results should be interpreted cautiously and in the context of the primary endpoint, rather than selected individually as definitive evidence.

Information about missing outcome data is not reported in the registry record. The record summarized for this trial does not specify how many participants lacked a primary assessment, why data might be missing, whether missing values were imputed, or how the analysis handled participants without both pre-dose and post-dose scores. A complete-case comparison and an analysis using imputation can rely on different assumptions; the registry does not identify which approach, if any, was used.

The analysis population is also not defined in the registry record. It does not state whether the primary result includes all randomized participants, only those who received the assigned dose, or a subset meeting other criteria. Randomized assignment is relevant to the intended comparison, but the posted group summaries alone do not establish the analysis population or show participant flow from assignment to outcome assessment.

These reporting gaps do not prove that missing data, multiplicity, or population definitions were mishandled. They limit independent assessment of how those issues were addressed. The protocol-level statistical plan, analysis population definitions, missing-data procedures, and any interim-analysis plans are not reported in the registry record.

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 4% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s adverse-event figures report no serious adverse events in either group among the 25 participants at risk in each group. Deaths are also recorded as 0 in both groups. For other adverse events, the registry records 2 affected participants in the cannabidiol group and 0 in the placebo group. These counts describe the posted registry data; they do not establish the cause of an event or compare risks with precision.

Small group counts provide limited information about uncommon harms. A count of 0 does not establish that an event cannot occur, and the registry record does not provide enough detail to assess event severity beyond the serious-versus-other grouping, timing, or clinical course. Specific event terms for serious adverse events are not reported in the registry record. The adverse-event figures should therefore be read as a concise account of what was posted, not as a comprehensive characterization of safety.

The listed safety outcome refers to treatment-related adverse events, but the registry’s summary does not supply detailed adjudication criteria or a full narrative of events. These results are distinct from the primary anxiety-score comparison and do not answer whether the primary endpoint changed. They provide limited descriptive safety information for the recorded groups.

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

The posted primary result describes the average short-term change in VAMS Anxiety Subscale T-score in two randomized groups receiving a single pre-imaging dose of cannabidiol or placebo. The estimated difference favors a more negative average change in the cannabidiol group under the registry’s subtraction order, but the interval is broad and includes values on both sides of no group difference. The unadjusted p-value is 0.277. Together, these findings leave substantial uncertainty about the size and direction of the average contrast.

This result does not show that the groups are equivalent. A non-significant or uncertain comparison is not proof that the true difference is absent; a study can be compatible with a range of possible effects when its estimate is imprecise. Conversely, the point estimate alone is not evidence that a meaningful difference has been established. The registry does not report a prespecified margin for equivalence or a clinical decision threshold for the between-group mean difference.

The reported endpoint is a self-reported mood subscale assessed around a scan. It does not measure long-term anxiety, sustained effects, outcomes from repeated use, cancer response, or other clinical outcomes. The trial is described as concerning acute anticipatory anxiety in people with advanced breast cancer before CT or PET imaging. Any interpretation beyond that population, intervention schedule, endpoint, and assessment window would extend beyond the posted evidence.

The registry’s interpretation thresholds concern changes in individual VAMS scores. The reported group contrast cannot show how many individuals had reliable or clinically significant changes, and the participant-level distribution is not reported. Likewise, a group mean does not imply that all participants experienced a similar change.

The record gives useful descriptive results but leaves analysis details unreported, including the confidence level, model, missing-data handling, analysis population, and multiplicity approach. These omissions matter when judging precision and robustness. The most defensible reading is therefore limited: the posted estimate is uncertain, and the registry record does not resolve whether a clinically important average difference exists.

17. Why This Trial Matters Statistically

This trial presents a focused statistical question: whether average acute change in a patient-reported anxiety score differs between a single cannabidiol dose and placebo before diagnostic imaging. Its randomized, double-blind, parallel design is suited to a between-group comparison, while the pre-dose and post-dose assessments make change over a short interval the central outcome. Keeping the interpretation tied to that question helps avoid extrapolating from one score and time window to broader outcomes.

The result also illustrates why an estimate should be read together with its uncertainty. The point estimate has a direction, but the posted interval spans possible contrasts on both sides of no difference. The p-value alone would not show that range, and neither the point estimate nor the p-value establishes clinical importance. Precision, outcome definition, and the analysis details available in the registry all shape what can reasonably be concluded.

The trial is also a useful example of the difference between individual thresholds and group comparisons. The VAMS description provides thresholds for interpreting changes within an individual, whereas the primary result compares group means. These quantities answer different questions. A group-level mean cannot identify how many participants crossed an individual threshold without participant-level or threshold-based summaries.

Finally, the registry’s planning illustration shows how assumptions about the effect to detect influence sample-size requirements. The figures are based on the observed effect and stated planning assumptions, not the original study design. Reading them as illustrations rather than as evidence of achieved power helps separate planning from the uncertainty in the observed result. The registry’s missing analysis details also show why clear reporting of populations, missing data, multiplicity, and interval methods is important for independent statistical interpretation.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The posted primary comparison includes 25 participants per arm, while the registry lists enrollment of 60. The record does not explain the difference between the enrollment field and the outcome-summary group sizes, or report participant flow, exclusions, or missing primary measurements. The final analyzed population and the extent to which it reflects all randomized participants are therefore unclear.

The registry does not report the analysis model, confidence level, interval method, analysis population, or missing-data approach. It also does not provide a prespecified threshold for a meaningful between-group difference. This limits assessment of robustness and makes it difficult to determine whether the reported uncertainty reflects all relevant sources of uncertainty.

The primary endpoint is a self-reported mood score measured within a brief period around one dose and a planned scan. It addresses an acute, context-specific experience; it cannot establish effects outside that setting or over a longer duration. Although the registry describes individual VAMS change thresholds, it does not report how many participants met them, so the posted group means do not show the distribution of potentially meaningful individual responses.

The registry lists secondary measures but does not report numerical results for all of them. It does not state how multiplicity was handled, and the posted unadjusted results should be interpreted accordingly. The safety summary also provides limited detail: event terms and clinical descriptions are not reported for the serious-event summary, and small group counts cannot rule out uncommon events.

Finally, masking is identified as double-blind, but the registry record does not describe who was masked or how masking was maintained. It does not report interim analyses or the trial’s original sample-size justification. These limitations are reporting limitations as well as constraints on interpretation; they should not be taken as proof that any particular procedure was absent.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: RCT of CBD for Anxiety in Advanced Breast Cancer — NCT04482244.
• Registry record last updated 2026-08-19; status last verified 2026-08.
• Results first posted 2025-07-29.
• 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 randomized, double-blind, parallel Phase II study of a single dose of cannabidiol versus placebo for acute anticipatory anxiety before CT or PET imaging in people with advanced breast cancer. The listed sponsor is Dana-Farber Cancer Institute. The registry lists enrollment of 60, a start date of 2022-01-19, primary completion on 2023-03-01, and status active, not recruiting.

The primary endpoint is change in VAMS Anxiety Subscale T-score from pre-dose to post-dose. The posted group summaries report 25 participants per arm and an unadjusted mean difference of -4.1 T-score, with an interval from -11.5 to 3.296 and an unadjusted p-value of 0.277. The interval includes possible differences in either direction, so the estimate remains uncertain.

The registry record does not report the confidence level, full analysis plan, missing-data handling, analysis population, or multiplicity procedure. Numerical reporting for secondary outcomes is incomplete, and the safety summary is brief. These limits constrain interpretation to the posted outcomes and the specific acute pre-imaging setting.