The Use of Jet Injection Lidocaine for Blood Draws in Young Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Use of Jet Injection Lidocaine for Blood Draws in Young Children (NCT01890642), a randomized na study. The primary outcome is Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial with enrollment of 205. The condition listed is pain, and the study status is completed. The record lists phase as not applicable. The sponsor was the Medical College of Wisconsin.

Participants were assigned to J Tip, Pain Ease, or J Tip Noise. The J Tip arm received 1% buffered lidocaine by jet injection. The Pain Ease arm received Pain Ease spray, while the J Tip Noise arm had the device deployed without medication to reproduce its noise. The arm descriptions also specify age-dependent use of sucrose and spray treatments: children older than 1 year and children younger than 1 year are described separately. The exact handling of a child aged 1 year is not reported in the registry record.

The primary outcome was the mean change in FLACC pain score between the initial assessment and venipuncture, with the timeframe stated as 3 min. Video reviewers assessed pain at J-tip deployment, J-tip noise, or researcher approach at 1 minute, and at venipuncture at 3 minutes. The registry record describes the initial score as subtracted from the venipuncture score.

The specific masking procedure, allocation ratio, randomization method, eligibility rules, and analysis population are not reported in the registry record. Nor are the original sample-size assumptions or the trial’s detailed statistical analysis plan. Enrollment and the arm-level outcome counts describe the posted record but do not establish which analysis population was used for each endpoint.

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 Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture, measured over 3 min.

The primary endpoint is the change in FLACC score from the initial assessment at device deployment, device noise, or researcher approach to venipuncture. The record gives a 3 min timeframe and describes video review at the initial assessment and at venipuncture. The FLACC scale evaluates face, legs, activity, cry, and consolability and ranges from 0 (no pain) to 10 (worst pain).

A change score asks whether the measured pain level shifted between two points in the procedure, rather than describing pain at only one moment. By subtracting the initial score from the score at venipuncture, a positive change represents a higher score at venipuncture than at the initial assessment; a smaller change indicates a smaller increase across those assessments. This interpretation concerns the measured scale, not a clinical judgment about an individual child.

The registry reports group means and standard errors for this outcome. A group mean describes the average change in the group, while the standard error describes uncertainty in estimating that mean. The record does not report a clinically important difference threshold, a minimally important change, or a justification for selecting this endpoint. It also does not report details of reviewer training or agreement, so the reliability of video scoring cannot be assessed from the registry record.

7. Results Posted in the Registry

• Pain Ease: mean 2.82 versus 1.71 on control; difference 1.11 (95% CI -0.10 to 2.32), standardized effect d = 0.35; z-test p = 0.071.
• J Tip: mean 0.23 versus 1.71 on control; difference -1.48 (95% CI -2.47 to -0.49), standardized effect d = -0.51; z-test p = 0.003.

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.

Fist Attempt Success

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Pain Ease: 90.6% (48/53) versus 92.9% (52/56) on control; risk difference -2.3 percentage points (95% CI -12.7 to 8.1), risk ratio 0.98 (0.87–1.09); unadjusted two-proportion z-test p = 0.664.
  • J Tip: 89.6% (86/96) versus 92.9% (52/56) on control; risk difference -3.3 percentage points (95% CI -12.4 to 5.8), risk ratio 0.96 (0.87–1.07); unadjusted two-proportion z-test p = 0.501.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Pain Ease and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between J Tip and the control. The interval gives the range of effects that remain compatible with the data.

Change in Pain Score From Baseline

• 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 errors.
• Result:
  • Pain Ease: mean 3.70 versus 2.32 on control; difference 1.38 (95% CI 0.04 to 2.72), standardized effect d = 0.39; z-test p = 0.044.
  • J Tip: mean 1.58 versus 2.32 on control; difference -0.74 (95% CI -1.86 to 0.38), standardized effect d = -0.23; z-test p = 0.195.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Pain Ease than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between J Tip and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes include pain score, fist-attempt success, change in pain score from baseline, and pain at J-tip deployment. Detailed arm results and recalculations are posted for fist-attempt success and change in pain score from baseline. Further detailed results for pain score and pain at J-tip deployment are not reported in the registry record.

Across the posted secondary results, the pattern is not uniform in statistical terms: the sponsor-reported tests indicate an overall group difference for change in pain score from baseline, while the reported test for fist-attempt success does not indicate a clear overall separation. These outcomes address different questions from the primary endpoint. A baseline change score concerns pain change relative to baseline, while fist-attempt success concerns procedural success rather than pain intensity. They can add context but do not replace the primary measure.

Secondary outcomes are generally less decisive when many outcomes and contrasts are examined without a reported multiplicity plan. Each additional test creates another opportunity for a chance finding. The registry does not report whether secondary testing was prespecified, whether results were adjusted for multiple testing, or how the secondary outcomes were prioritized. For that reason, unadjusted secondary results carry less weight than a clearly specified primary analysis and should be treated as supportive or exploratory rather than as independent confirmation.

The registry lists four secondary outcome titles, but detailed numerical results for all four are not reported in the registry record. No conclusion about the unreported outcomes can be drawn from the results that are posted. The secondary findings also do not establish whether any observed score changes meet a clinically meaningful threshold, because such a threshold is not reported.

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

• Pain Score
• Fist Attempt Success
• Change in Pain Score From Baseline
• Pain at J-tip Deployment

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous and reported as a mean with a standard error. A mean is the arithmetic average of observations in a group. A standard error describes how precisely that average is estimated; it is not the standard deviation, which describes spread among individual observations. The registry does not post standard deviations for the primary endpoint, but the recalculated comparisons include pooled standard deviations derived from the posted summaries.

The sponsor’s reported primary analysis is a Kruskal-Wallis test. In general, this is a rank-based method for assessing whether observations across multiple independent groups have similar distributions. It works with ranks rather than directly comparing group means. A statistically notable overall result indicates that the group distributions are not all alike under the test; it does not specify which pairs differ. The registry gives a p-value but does not report the test statistic, degrees of freedom, or pairwise follow-up tests. The assumptions and implementation details beyond the method name are not reported in the registry record.

The recalculated pairwise results instead express differences between group means. In general, a mean difference is the mean in one group minus the mean in the comparison group, in the order stated for that contrast. A positive or negative sign depends on that order. The recalculated confidence intervals describe a range of values compatible with the summary data under the calculation’s assumptions. If an interval includes zero, the data are compatible with no mean difference as well as with differences in either direction at the interval’s stated confidence level. The confidence level itself is not specified in the posted comparison fields.

The recalculations are unadjusted. In general, an unadjusted pairwise test evaluates one contrast without correcting for the fact that several outcomes or contrasts may be examined. Testing many comparisons increases the chance that at least one result appears notable by chance. Such recalculations can help describe the posted means, but they are not a substitute for the sponsor’s analysis plan or for any multiplicity procedure the sponsor may have used. That procedure is not reported in the registry record.

General explanation of over-dispersion: over-dispersion occurs when observed variability is greater than a statistical model expects. A model that understates variability can make standard errors too small and intervals too narrow. No over-dispersion assessment or model-based primary analysis is reported for this endpoint; the sponsor’s named test is rank-based. The registry does not provide individual observations, so distributional shape, outliers, and within-group variability cannot be examined from the posted summaries.

The posted secondary fist-attempt outcome is binary: success or no success. In general, binary outcomes can be described as counts or proportions, and a risk difference compares the proportions between groups. The listed recalculations also include relative measures, but interpreting those measures requires attention to their comparison order and uncertainty. The sponsor’s reported test for this secondary outcome is again listed as Kruskal-Wallis, even though the outcome is described as a number of participants. The registry does not explain this method choice or provide additional detail about how it was implemented.

For planning, the sample-size illustrations use the observed effect or a stated fraction of it, two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. These calculations are illustrations based on the posted estimates, not a reconstruction of the trial’s original design. The original design assumptions and sample-size justification are not reported in the registry record. General statistical interpretation: planning based on an observed effect can be optimistic because the observed estimate is uncertain, especially when derived from a single trial.

Randomization can support a causal comparison when assignment is implemented as planned and the analysis preserves the randomized groups, but the registry record does not supply enough detail to assess those conditions. The masking is listed as single, without specifying who was masked. Missing-data methods, analysis populations, and handling of protocol deviations are not reported in the registry record. Those omissions limit assessment of bias and reproducibility.

11. Confidence Intervals and Precision

The recalculated primary contrasts have different degrees of precision. For Pain Ease compared with J Tip Noise, the estimated mean difference is 1.11 and its interval extends from -0.096 to 2.316. Because the interval crosses zero, it is compatible with no difference as well as with effects in either direction. For J Tip compared with J Tip Noise, the estimate is -1.48 and the interval extends from -2.469 to -0.491. This interval lies below zero, indicating a lower mean change for J Tip in this unadjusted comparison.

A confidence interval is a way to express uncertainty in an estimate. In general, a wider interval indicates less precision, while a narrower interval indicates greater precision, conditional on the method and its assumptions. The posted fields do not state the confidence level for these recalculated intervals, so it should not be inferred from the record. An interval is not a range containing a fixed proportion of individual children’s outcomes, and it does not account for every possible source of bias.

The standard errors attached to the group means also convey precision of the estimated averages. They do not describe the spread of individual FLACC changes. In general, a group mean can be estimated precisely even when individual values vary substantially, or imprecisely when the information is limited. The registry does not provide individual-level results or the full score distributions needed to explore that distinction.

Precision should be considered alongside the overall Kruskal-Wallis result, the contrast estimates, and the endpoint’s clinical meaning. The sponsor’s overall test addresses the three-group comparison, whereas the recalculated intervals describe particular mean contrasts. These results cannot be treated as interchangeable. The registry does not report a clinical importance threshold, so the intervals alone cannot determine whether any compatible difference would matter in practice.

12. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total trial enrollment figures. The posted sample-size assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The calculations use the observed effect or a stated fraction of that effect. These are planning illustrations; the original design assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrated number of participants per arm for a design with an 80% chance of detecting the specified effect under those assumptions, if that effect is real and the model assumptions hold. The 90% power column gives the corresponding planning target for a higher chance of detection. Power is a property of a proposed design for a specified effect, not a description of what happened in the completed trial.

For example, planning for 100% of the observed primary mean difference for J Tip versus J Tip Noise gives 61 participants per arm for 80% power and 81 participants per arm for 90% power. Planning for 75% of that observed effect gives 107 participants per arm for 80% power and 144 participants per arm for 90% power. The pattern illustrates why smaller effects need more participants: a less pronounced difference is harder to distinguish from random variation under otherwise similar assumptions.

These figures are not observed power. They rely on the effect estimates from this trial, which have uncertainty, and do not show the probability that the study’s conclusion is correct. They should be read as conditional planning examples rather than evidence about the adequacy of the original design.

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 = 1.110; pooled standard deviation σ = 3.208.
2. n = 2 × (1.96 + 0.842)² × 3.208² / 1.110² = 131.1, rounded up to 132 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 <- 1.11                      # observed difference in means
sigma <- 3.20834484360924                     # 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(1890642)
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 = 132 (80% power), 176 (90% power)
 75% of observed effect: n per arm = 234 (80% power), 313 (90% power)
 50% of observed effect: n per arm = 525 (80% power), 703 (90% power)
power.t.test: 132.1 
Simulated power at n = 132 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s sponsor-reported primary analysis is a Kruskal-Wallis comparison across J Tip Noise, Pain Ease, and J Tip, with p < 0.001. This is the sponsor’s reported overall test of the three groups. The registry does not provide a sponsor-reported pairwise estimate or interval for the primary endpoint.

The posted recalculations compare group means using the summary statistics. They include unadjusted pairwise p-values and intervals, and therefore answer narrower questions than the overall rank-based test. Their estimates may be useful for describing the magnitude and direction of mean contrasts, but they are not the sponsor’s analysis. Because the record flags a discrepancy between the sponsor-reported analysis and recalculations, the sponsor’s own analysis takes precedence.

That precedence does not mean the recalculations are necessarily erroneous; they use a different comparison and statistical approach. Nor does the overall test establish which specific pairs differ. The registry record does not explain the discrepancy, identify a preferred pairwise method, or report the sponsor’s detailed analysis plan. Conclusions should therefore distinguish the sponsor’s overall finding from the exploratory, unadjusted mean contrasts rather than blending them into a single claim.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, group contrasts, time points, or analyses are evaluated. Even when each test is conducted properly, examining many tests without adjustment makes it more likely that at least one result will appear statistically notable by chance. This matters in a three-group trial with a primary endpoint and multiple secondary outcomes, especially when pairwise comparisons are considered in addition to an overall test.

The registry reports an overall Kruskal-Wallis p-value for the primary endpoint and also provides recalculated pairwise comparisons. It does not report whether the sponsor conducted pairwise follow-up tests, whether any adjustment for multiple comparisons was used, or which outcomes were designated as confirmatory. The multiplicity strategy is not reported in the registry record. The posted recalculated p-values are unadjusted and should not be interpreted as if they account for all possible analyses.

Missing-data handling is also not reported in the registry record. The record does not describe how missing pain assessments were handled, whether participants with incomplete video observations were excluded, or whether any sensitivity analyses were performed. The numbers contributing to an endpoint need not necessarily represent the full randomized population, and the registry does not specify the analysis population for each result.

Further details about the intention-to-treat principle, per-protocol analyses, protocol deviations, and imputation are not reported in the registry record. Without these details, it is difficult to assess whether missingness or exclusions could have affected comparisons. The record also does not provide the original statistical analysis plan or enough information to determine which analyses were prespecified. These reporting gaps limit evaluation of selective reporting and the robustness of the results.

16. Safety Results

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

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The serious adverse event record reports 0 affected participants in each arm: J Tip Noise had 0 among 56 at risk, Pain Ease had 0 among 53 at risk, and J Tip had 0 among 96 at risk. These figures mean that no serious adverse events are listed as affecting participants in the posted record during the recorded period. They do not establish that no serious events could occur, nor do they describe risks outside the trial’s observation and reporting.

The record also lists other adverse events separately, with affected counts of 6, 6, and 13 among the respective at-risk counts of 46, 46, and 83. These are not serious adverse event counts and should not be conflated with them. The record does not give event terms in the posted adverse-event details, and deaths are not reported in the registry record. Details such as event severity, timing, relatedness, and the observation period are not reported in the registry record.

Zero reported serious events is a descriptive finding, not proof of safety. A trial’s adverse-event data need to be interpreted in light of its size, follow-up, event definitions, and completeness of reporting; those details are not fully available in the registry record.

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

The posted results describe changes in video-assessed FLACC pain scores during venipuncture across three randomized groups. The sponsor-reported overall analysis indicates a difference among the group distributions. The posted group means and recalculated contrasts give additional descriptive context, but the recalculations are unadjusted and do not replace the sponsor’s reported analysis.

The outcome is a score on a defined scale, not a direct measure of every aspect of a child’s experience. A lower average change does not show how every child responded, and the summary statistics do not reveal the full distribution of scores. The registry does not report a threshold for a clinically important change, so statistical evidence of a difference cannot by itself establish how meaningful that difference would be to patients, caregivers, or clinicians.

The findings also cannot establish the effect of each treatment under every circumstance. The groups’ age-dependent co-interventions are described in the arm text, and the registry record does not provide enough detail to disentangle the contribution of each component. The exact masking procedures, missing-data handling, analysis populations, and full protocol are not reported in the registry record. Those limits matter when considering possible sources of bias or the extent to which the findings apply beyond the recorded trial.

The adverse-event entries report no serious adverse events in the posted record, but this does not prove an absence of risk. Likewise, a statistically notable result is not a guarantee of replication or an instruction for clinical care. The appropriate reading is limited to what the registry reports: observed group summaries, a sponsor-reported overall test, and unadjusted recalculations with their stated uncertainty.

18. Why This Trial Matters Statistically

This trial illustrates how the choice of statistical question affects interpretation. The sponsor’s Kruskal-Wallis test evaluates an overall difference across three groups using ranks, while the recalculated mean differences quantify particular pairwise contrasts in average pain-score change. Both can be informative, but they are not interchangeable. A significant overall test does not identify the responsible pair, and a pairwise mean comparison does not reproduce the sponsor’s overall rank-based analysis.

It also demonstrates why estimates and uncertainty deserve attention alongside p-values. The mean contrasts have different directions and interval widths, and their intervals communicate which values remain compatible with the recalculation. The group standard errors describe precision of estimated means, not variation among individual children. Keeping these concepts distinct helps avoid treating a statistical test as a complete description of an outcome.

The record further highlights the importance of prespecified analysis and transparent reporting. The multiplicity approach, missing-data methods, analysis populations, original sample-size rationale, and detailed masking procedures are not reported in the registry record. Without them, readers cannot fully assess the risk of selective emphasis or the robustness of the findings. Planning illustrations based on observed effects are also not evidence of the trial’s original design or of its achieved power.

These are general lessons for clinical research: define the estimand and analysis in advance, report estimates with uncertainty, explain how multiple outcomes are handled, and make analysis populations and missing-data decisions explicit. The trial’s posted statistics make clear why those details are important for moving from a numerical result to a properly bounded interpretation.

19. 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 primary outcome relies on video-based FLACC scoring, but the registry record does not report reviewer training, masking of reviewers, scoring reliability, or procedures for resolving disagreements. It therefore is not possible to assess how consistently the score was applied or whether reviewers could infer group assignment.

The intervention descriptions include different age-dependent co-interventions: Pain Ease spray or sucrose in the comparison groups, placebo cooling spray or sucrose in the J Tip group, and J-tip device noise in the J Tip Noise group. The record does not explain the exact treatment of children aged 1 year or provide enough detail to separate the effects of lidocaine, spray, sucrose, and device noise. These features complicate interpretation of a comparison as the effect of a single component.

The registry gives arm-level means and standard errors but not individual data or full distributions. The bounded FLACC scale may yield distributions that are not well described by means alone. The sponsor used a rank-based overall test, whereas the recalculated contrasts compare means; the record does not give enough statistical detail to assess the discrepancy fully.

Additional limitations include unreported eligibility criteria, allocation ratio, randomization procedure, masking roles, analysis populations, missing-data methods, protocol deviations, and multiplicity handling. The record does not state a clinically important threshold for the scale. Although adverse-event counts are posted, event terms and relevant follow-up details are not reported in the registry record. These omissions restrict assessment of internal validity, clinical relevance, and generalizability.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: The Use of Jet Injection Lidocaine for Blood Draws in Young Children — NCT01890642.
• Registry record last updated 2015-10-06; status last verified 2015-09.
• Results first posted 2015-10-06.
• 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.

23. Record Summary

The registry record describes a completed randomized, single-masked, parallel-group trial with enrollment of 205, sponsored by the Medical College of Wisconsin. It compared J Tip with buffered lidocaine, Pain Ease spray, and a J Tip Noise comparison for pain during venipuncture in children age 6 and younger.

The primary endpoint was change in FLACC pain score from the initial assessment to venipuncture. The sponsor reported an overall Kruskal-Wallis result of p < 0.001. Unadjusted recalculations provide pairwise mean differences, but the record flags a discrepancy, so the sponsor’s own analysis takes precedence. Secondary outcomes include pain and fist-attempt success; detailed results for every listed secondary outcome are not reported in the registry record.

The record lists no serious adverse events in the three arms. Important details about the analysis plan, missing data, multiplicity, and original sample-size justification are not reported in the registry record.