Advocating for Supports to Improve Service Transitions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Advocating for Supports to Improve Service Transitions (NCT04173663), a randomized na study. The primary outcome is Treatment Target: Change in Parental Empowerment Scale.

2. Clinical Question

The study’s stated aim was to develop and test a national curriculum for parent intervention training. Its intended target was parents’ ability to advocate for services that support their youth’s transition to adulthood. The primary outcome addresses a proposed intervention target—parents’ reported sense of empowerment—rather than directly measuring whether services were obtained or whether youth experienced a particular transition outcome.

The registry record reports group-level change scores and a sponsor-reported linear regression analysis. Those are not presented as the same statistical result: the unadjusted recalculation from the posted summaries differs from the sponsor’s analysis. The sponsor’s own analysis takes precedence when interpreting the trial’s reported statistical test, while the recalculation describes a separate, simple comparison of posted summary statistics.

3. Trial Design

The registry record describes Project ASSIST as a randomized, single-masked, parallel-group behavioral study. It lists the study as completed and gives an enrollment of 185. The record lists Vanderbilt University Medical Center as sponsor and identifies autism spectrum disorder and autism as conditions. Phase is recorded as NA.

Participants were assigned to ASSIST or to a written-materials-only control. The intervention description specifies 12 weekly sessions, each lasting 2 hours. The control group received the program binder and written materials on the same schedule but did not attend group sessions. The record also says that written materials were provided after the treatment group was treated and follow-up data were collected for comparison; the available description ends before giving further details about that arrangement.

The study began on 2020-01-03, and the primary completion date is 2022-03-01. The registry summary describes a change in delivery during the COVID-19 pandemic. An in-person intervention series that began in Winter 2020 was paused in Spring 2020 for Cohort 1 groups in TN and IL, then resumed in Summer 2020 by synchronous web-conferencing. In Fall 2020 the program was permanently moved to synchronous web-conferencing, which was used for remaining sessions and series at all sites: TN, IL, and WI. Some baseline collection also moved to remote online interviews and questionnaires. Follow-up and check-in collection used web conference and/or phone calls as well as online surveys.

The record does not report the randomization sequence method, allocation concealment, the masking role, or the original design assumptions. It also does not describe the specific statistical analysis plan in sufficient detail to establish how the sponsor’s model handled baseline values or other covariates.

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: The data reported only includes parents who were enrolled in the study. Youth did not receive the intervention. For the purposes of primary and secondary outcome measure reporting youth were not considered enrolled and data was not collected

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.

Population: The data reported only includes parents who were enrolled in the study. Youth did not receive the intervention. For the purposes of primary and secondary outcome measure reporting youth were not considered enrolled and data was not collected.

6. Primary Endpoint

The registry lists the primary outcome as Treatment Target: Change in Parental Empowerment Scale, measured over Baseline to intervention-end, up to month 10.

The primary outcome is titled “Treatment Target: Change in Parental Empowerment Scale.” It measures change from baseline to intervention end, with the endpoint described as occurring up to month 10. The instrument is the Family Empowerment Scale (FES), a 34-item questionnaire about the extent to which parents feel empowered across family, service-system, and broader community and political-environment dimensions.

Each item uses a 5-point Likert scale, anchored from “not at all true” to “very true.” The total score can range from 34 to 170, with higher scores indicating greater reported empowerment. The reported outcome is a mean change score, with standard deviations describing the spread of individual scores within each group.

Empowerment is relevant to the stated intervention because ASSIST trains parents to advocate for services. A scale focused on parents’ perceived empowerment can therefore assess whether a proposed target of the training changed. It is not itself a direct measure of service access, service receipt, youth social participation, or transition outcomes. Those domains appear among the registry’s secondary outcomes, but they represent different questions and should not be treated as interchangeable with the primary measure.

The registry record does not report the primary-outcome population in its population description. It also does not provide item-level scoring details beyond the scale description, or explain how missing items were handled when calculating a total or change score.

7. Results Posted in the Registry

• ASSIST Intervention Group: mean 4.93 versus 0.61 on control; difference 4.32 (95% CI 0.22 to 8.42), standardized effect d = 0.31; z-test p = 0.039.

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.

Social Participation Youth Outcomes

• 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:
  • ASSIST Intervention Group: mean 0.13 versus -0.72 on control; difference 0.85 (95% CI -0.67 to 2.37), standardized effect d = 0.19; z-test p = 0.272.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASSIST Intervention Group and the control. The interval gives the range of effects that remain compatible with the data.

Access to Services Interview: Barriers to Service Receipt

• 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:
  • ASSIST Intervention Group: mean 2.66 versus 2.71 on control; difference -0.05 (95% CI -0.69 to 0.59), standardized effect d = -0.03; z-test p = 0.878.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASSIST Intervention Group and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover youth social participation, unmet service needs, and barriers to service receipt. Across the posted unadjusted comparisons, the pattern is not a consistent set of clear between-group differences: estimates vary in direction, and the reported confidence intervals include zero. The sponsor-reported regression p-values also do not indicate a clear statistical separation for these outcomes. These findings are best read as uncertain estimates rather than proof of equivalence or proof that no differences exist.

The secondary measures are related to the trial’s broad goal of supporting service transitions, but they assess different constructs from the primary parental empowerment scale. The primary result concerns parents’ reported empowerment; youth social participation and service-access measures concern other outcomes. A result on one construct does not automatically establish a result on another, and the secondary pattern neither confirms nor refutes the primary finding.

Secondary results carry less weight when many outcomes or analyses are examined without a reported multiplicity adjustment. Repeated testing increases the chance that at least one result will appear notable even if there is no underlying effect. The registry lists 10 outcome measures and 16 analyses, but does not report a multiplicity plan or an adjustment for multiple comparisons. The record also does not identify a hierarchy among all secondary hypotheses.

Accordingly, secondary outcomes are useful for describing the range of measured domains and the direction and uncertainty of estimates. They should not be treated as independent confirmatory evidence simply because they are reported, particularly when analysis details and multiplicity handling are not reported in the registry record.

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

• Social Participation Youth Outcomes
• Change in Access to Services Interview: Unmet Service Needs
• Access to Services Interview: Barriers to Service Receipt

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a scale score expressed as change from baseline. The registry reports each group’s mean change and standard deviation, then lists a sponsor analysis using linear regression. These methods answer related questions but need not produce identical estimates, particularly when one result is a simple unadjusted comparison and the other comes from a regression model whose details are not reported.

What does the mean difference describe?

A mean difference compares the average outcome in one group with the average in the other. For the posted primary summaries, the recalculated contrast is the ASSIST group’s mean change compared with the written-materials group’s mean change. It is an unadjusted summary-statistic calculation; it does not account for other variables or establish that the groups were compared using the sponsor’s model. The direction of a difference depends on which group is subtracted from which, so the group labels and stated contrast matter.

A standard deviation describes how spread out individual scores are around a group mean. It is different from a standard error, which describes uncertainty in an estimated mean. The primary group standard deviations are 13.72 and 14.02. The record also includes standard errors for the group means in its recalculation details. Those quantities should not be interchanged: a group can have substantial variation among individual scores while the estimated group mean has a smaller standard error.

What does the regression result describe?

Linear regression models the relationship between an outcome and one or more predictors. The registry reports a linear regression slope for the comparison, but it does not report the model equation, covariates, coding of the group indicator, or whether baseline outcome values were included. A slope’s sign depends on how the predictor and outcome are coded. Without those details, the negative slope of -3.27 should be reported as recorded, not converted into a more specific interpretation of the group contrast.

The regression p-value is .092, and the record gives no confidence interval for that slope. The unadjusted recalculation has a different estimate and p-value. The record does not explain the discrepancy. For the trial’s own analysis, the sponsor’s reported result takes precedence; the recalculation is useful as a transparent comparison based on the posted means and standard deviations, not as a replacement analysis.

Why do confidence intervals matter?

A confidence interval describes a range of values compatible with the data and the method used, subject to the assumptions of that method. It communicates uncertainty about the estimated contrast, not the probability that a particular interval contains the true effect. A wide interval indicates less precision than a narrow one. Whether an interval includes zero is relevant to a test of no mean difference under the corresponding method, but it does not determine whether all values in the interval are practically important or unimportant.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model expects. When a model assumes less variability than the data contain, standard errors can be too small and confidence intervals too narrow, making statistical evidence appear stronger than it is. The primary outcome is analyzed as a continuous scale measure, and the record does not report an over-dispersion assessment. This general issue should not be taken to mean that over-dispersion was present in this trial.

What does a p-value say?

A p-value describes how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or a measure of effect size. The recalculated unadjusted p-value and the sponsor’s regression p-value arise from different reported analyses. Since they disagree, the sponsor’s result is the primary reference for the trial’s own analysis, while the unadjusted value should remain clearly labeled as a recalculation.

General statistical interpretation also depends on model assumptions, outcome measurement, and how observations enter the analysis. Randomization supports a planned between-group comparison, but it does not remove the need to describe allocation, analysis populations, missing data, and model specification. Those details are not reported in the registry record, so the precision and meaning of the sponsor’s regression result cannot be fully assessed from the registry entry alone.

11. Confidence Intervals and Precision

The unadjusted primary mean difference is 4.32 points, and its reported 95% confidence interval extends from 0.222 to 8.418. This interval is entirely on the positive side of zero, but its range spans estimates from close to no difference to a larger positive contrast. The interval therefore conveys uncertainty about the size of the unadjusted difference; it does not establish that every value within the range has the same practical significance.

The corresponding unadjusted p-value is 0.039. That value is tied to the recalculation and should not be conflated with the sponsor’s regression p-value of .092. The sponsor’s analysis has no confidence interval reported in the registry. Consequently, its precision cannot be judged from an interval estimate, and the discrepancy between analyses remains unresolved.

Precision is distinct from statistical significance and from clinical or practical importance. An interval may help show which effect sizes are compatible with the data, but interpreting importance requires context about the scale and what degree of change would matter. The registry record does not state a threshold for a meaningful change on the FES, nor does it report a minimal important difference.

For the secondary outcomes, the reported unadjusted intervals include values on both sides of zero. Their estimates therefore leave room for different directions of effect under those calculations. As with the primary outcome, these are unadjusted comparisons rather than replacements for the sponsor-reported regression analyses. The registry does not provide confidence intervals for the sponsor’s reported slopes.

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 illustrations express required sample sizes as participants per arm for each stated effect fraction and target power. They are not totals across arms and do not report total events. The assumptions stated for these illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. These are planning assumptions for the illustration; the trial’s original design assumptions are not reported in the registry record.

The 80% power column gives the number of participants per arm that the illustration estimates would be needed for an 80% chance of detecting the chosen effect under those assumptions, if that effect and model are appropriate. The 90% power column applies the higher target probability and accordingly gives a larger planning requirement. These are planning calculations based on the observed effect, not a statement about the probability that this completed trial detected an effect.

The primary-outcome illustrations are 162 participants per arm for 80% power and 217 for 90% power when planning for 100% of the observed effect. For 75% of the observed effect, the corresponding figures are 288 and 386. For 50% of the observed effect, they are 648 and 867. The smaller the effect targeted, the more participants the illustration requires, because a smaller group contrast is harder to distinguish from variability.

These figures should not be read as the study’s actual enrollment target or as a retrospective judgment about whether the trial was adequately sized. They use the observed effect as a planning input, and observed effects can be uncertain. This is not observed power. The record does not report the original sample-size justification or the assumptions used when the study was designed.

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 = 4.320; pooled standard deviation σ = 13.871.
2. n = 2 × (1.96 + 0.842)² × 13.871² / 4.320² = 161.8, rounded up to 162 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 <- 4.32                      # observed difference in means
sigma <- 13.8708110793854                     # 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(4173663)
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 = 162 (80% power), 217 (90% power)
 75% of observed effect: n per arm = 288 (80% power), 386 (90% power)
 50% of observed effect: n per arm = 648 (80% power), 867 (90% power)
power.t.test: 162.8 
Simulated power at n = 162 per arm: 0.795 (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 reports the sponsor’s primary analysis as a linear regression with slope -3.27 and p = .092. No confidence interval is reported for this estimate. The simple unadjusted recalculation from the posted group summaries gives a mean difference of 4.32, a 95% confidence interval from 0.222 to 8.418, and an unadjusted p-value of 0.039. The two analyses therefore do not give the same estimate or statistical conclusion.

The recalculation is a basic comparison of posted summary statistics. It is not the sponsor’s model and does not supersede it. Because the discrepancy flag is true, the sponsor’s own analysis takes precedence when describing the trial’s reported result. The recalculation can still be presented as an independent, unadjusted reading of the group-level summaries, provided it is clearly separated from the sponsor result.

The registry does not report enough model detail to determine why the analyses differ. In particular, the regression specification, outcome and group coding, covariate adjustment, and analysis population are not described. It would be speculation to attribute the difference to any one of these factors. The appropriate interpretation is to preserve the distinction between the analyses, state the sponsor result as reported, and avoid treating the unadjusted recalculation as the definitive trial analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures and 16 analyses. It does not report whether the study prespecified a hierarchy among outcomes, controlled the overall type I error rate, or adjusted secondary p-values for multiple testing. When researchers test many outcomes or contrasts, the chance of at least one apparently unusual result can increase. A multiplicity strategy helps define how evidence should be interpreted across a family of tests. Without a reported strategy, secondary p-values are more appropriately treated as exploratory or descriptive rather than as stand-alone confirmation.

Missing-data handling is also not reported in the registry record. The primary endpoint summaries list 88 participants in each group, while the posted secondary outcome counts differ by outcome and are smaller than the primary counts. These differing analysis counts make it important to know whether observations were unavailable, excluded, or otherwise handled, but the registry does not explain the reasons or methods. No assumption about the mechanism of missingness, imputation, or sensitivity analysis can be made from the reported information.

The analysis population is not described in enough detail to determine whether results were based on all randomized participants, participants with observed outcomes, or another population. Although the study is described as randomized, the record does not specify an intention-to-treat analysis or give a per-protocol definition. It also does not report how deviations from assigned intervention were handled.

The sponsor’s regression model is identified as linear regression, but the model specification and covariates are not given. The record does not say how baseline scores entered the model, whether assumptions were checked, or how the remote changes in delivery and data collection were handled analytically. These omissions limit assessment of the reported estimates and of how robust they are to analytic choices.

16. 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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events as zero in the ASSIST group and zero in the written-materials control group. The listed numbers at risk for serious adverse events are 91 and 94, respectively. The record also reports zero deaths in each group.

For other adverse events, the record lists 17 affected participants in each group, with 91 and 94 at risk, respectively. These are counts, not rates, and should be read alongside the group-specific numbers at risk rather than compared as if the denominators were identical. No serious adverse-event terms are listed.

These registry figures describe what was reported for the study; they do not establish that no adverse events occurred beyond those captured or submitted. The record does not provide event-level descriptions, severity or relatedness assessments for the other events, or details of how adverse events were collected. Safety counts also do not answer the primary question about change in parental empowerment.

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

The results address a specific question: whether parental empowerment changed from baseline to intervention end, up to month 10, in a randomized comparison of ASSIST training with written materials alone. The posted summary statistics yield an unadjusted positive mean difference. The sponsor’s own regression analysis reports a different result, with slope -3.27 and p = .092. Because the analyses disagree, the sponsor’s result takes precedence as the trial’s reported analysis, while the summary-statistic recalculation remains a separate descriptive calculation.

Neither a p-value nor a confidence interval determines whether a change matters to families. The registry record does not report a threshold for a meaningful change in FES score. The outcome measures parents’ reported empowerment, not whether a particular service was obtained, whether service barriers were removed, or whether a youth’s transition to adulthood improved.

The study’s broad objective was to develop and test a parent advocacy curriculum. Its reported findings should therefore be interpreted in the context of the outcomes actually measured, their analysis populations, and the uncertainties around the estimates. The record’s missing details about model specification, missing data, and multiplicity make stronger claims difficult to support.

The results do not establish that ASSIST works or does not work. They do not show that the groups were equivalent, and the absence of a clear result in a particular analysis is not proof of no effect. Conversely, the positive unadjusted contrast does not by itself establish a causal or practically important change. The clearest conclusion is that the registry reports differing primary analyses and leaves important analytic details unreported.

18. Why This Trial Matters Statistically

This trial illustrates why a reported treatment contrast should be interpreted together with its analysis method. A mean difference recalculated from group summaries can be useful for understanding the posted data, but it is not automatically the same estimand as a sponsor’s regression coefficient. When the two results disagree, separating them prevents a simple calculation from being mistaken for the trial’s own analysis.

It also shows why a single p-value is not a sufficient summary. Effect estimates and confidence intervals describe magnitude and uncertainty, while p-values address compatibility with a null model under specified assumptions. The sponsor’s analysis has no confidence interval reported, limiting assessment of its precision. The recalculation has an interval, but it does not resolve the discrepancy or substitute for the sponsor analysis.

The endpoint itself matters. Parental empowerment is a plausible intervention target for a parent advocacy program, but it is not the same as service access or youth participation. Statistical interpretation needs to stay aligned with the construct measured rather than extending the result to broader outcomes that were not established by the primary endpoint.

Finally, this record illustrates the importance of transparent reporting. Details about the regression model, missing data, analysis population, multiplicity, and original sample-size assumptions are not reported. These are not minor technicalities: they shape how readers judge precision, bias, and the strength of evidence. The available registry information supports a cautious account of the observed estimates, while leaving questions that would require fuller analytic reporting.

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.

Several limitations are specific to the information reported for this trial. The primary recalculation and the sponsor’s regression result differ, and the registry does not provide the model details needed to explain that discrepancy. The regression slope is reported without a confidence interval, limiting direct assessment of its precision.

The record does not describe the randomization procedure, allocation concealment, or which role was masked. It also does not explain the analysis population or how missing outcome data were handled. The primary outcome counts and secondary outcome counts differ, but reasons for those differences are not reported. It is therefore not possible to assess from the registry entry whether missingness could have influenced the comparisons.

The intervention delivery changed during the COVID-19 period: initial in-person sessions were paused, then resumed by synchronous web-conferencing, and the program was permanently moved to that delivery method for remaining sessions and series at all sites. Baseline and follow-up data collection also moved to remote methods. The record does not report whether delivery mode or data-collection mode was considered in the analysis, or whether outcomes differed by cohort or site.

The registry does not report the original sample-size justification, the study’s multiplicity approach, or a meaningful-change threshold for the FES. These gaps restrict interpretation of the planning illustrations and the practical significance of the primary estimate. Finally, the record’s brief summary says final data collection will be complete by Summer 2023, while the study status is listed as completed and the primary completion date is 2022-03-01. The record does not explain this timing detail.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Advocating for Supports to Improve Service Transitions — NCT04173663.
• Registry record last updated 2025-01-31; status last verified 2024-12.
• Results first posted 2025-01-31.
• 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

Project ASSIST is recorded as a completed, randomized, single-masked, parallel-group behavioral study sponsored by Vanderbilt University Medical Center. It compared a 12-session parent advocacy training program with written materials alone. The primary endpoint was change in parental empowerment measured by the Family Empowerment Scale, from baseline to intervention end, up to month 10.

The unadjusted recalculation from posted primary summaries reports a mean difference of 4.32, while the sponsor’s linear regression reports a slope of -3.27 with p = .092. The discrepancy means the sponsor’s result takes precedence as the trial’s own analysis; the record does not explain why the analyses differ. Secondary outcomes cover social participation and service-access domains, but their results are not a consistent basis for a broader conclusion.

Important details—including the regression specification, missing-data methods, analysis population, multiplicity handling, and original sample-size assumptions—are not reported in the registry record. The findings should be read as estimates for the stated outcomes, with those reporting limitations in view.