Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory) (NCT01374269), a randomized phase 4 study. The primary outcome is Visual Analogue Scale of Pain.

2. Clinical Question

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group, phase 4 trial, with enrollment of 90. The study is listed as completed. Its official title identifies Medellín, Colombia, and 2009-2010; the recorded start is 2009-06 and primary completion is 2011-10. The sponsor is Grupo Rehabilitacion en Salud.

One group was assigned to a protocolized exercise program and the other to NSAID treatment. The exercise description specifies sessions three times a week for 4 weeks, delivered by physiotherapists from participating institutions. The NSAID arm description names naproxen 500 mg per day for 10 days or celecoxib 200 mg per day for 10 days, with acetaminophen 1,5 a 2 g as rescue medication. How the choice between the named NSAIDs was made is not reported in the registry record.

The arm summaries contain 46 participants in the exercise group and 44 in the NSAID group. The masking label is triple, but the identities of the masked parties and practical masking procedures are not reported in the registry record. Random-sequence generation, allocation concealment, treatment adherence, crossover, and the handling of deviations from assigned treatment are also not reported in the registry record.

The study description refers to a 6-months follow-up, but the posted primary and secondary summaries are all marked “At the beginning.” No follow-up outcome estimates are reported in the registry record. Consequently, the posted group summaries address baseline measurements, not the stated follow-up comparison.

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: A specific cause for the pain (infection, tumor, ankylosing spondylitis, inflammatory conditions or cauda equine syndrome), the presence of red flags, scoliosis \>15 °, depression or mental illness, history of gastrointestinal bleeding, renal failure, intake of anticoagulants or antiplatelet drugs and NSAID allergy were excluded.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as Visual Analogue Scale of Pain, measured over At the beginning.

The primary endpoint is the Visual Analogue Scale of Pain, recorded in units on a scale. The registry description defines 0 as no pain and 100 as maximum pain, with lower scores representing less pain. A visual analogue scale is used to represent a person’s reported pain intensity on a continuous range, rather than restricting responses to a small set of categories. In general, that can retain gradations in reported experience and allow a mean score to be summarized across participants.

The registry lists the outcome parameter as a mean and its dispersion as a standard deviation. The posted exercise-group mean at the beginning is 47.3, with a standard deviation of 19.8, among 46 participants. The NSAID-group mean is 45.2, with a standard deviation of 22.6, among 44 participants. These values are baseline descriptions. They are not follow-up measurements or changes from baseline.

The trial description says its purpose was to evaluate pain, function and quality of life during a 6-months follow-up. However, the primary outcome timeframe recorded in the results is “At the beginning.” A baseline measure can describe the groups’ starting pain levels, but a treatment comparison ordinarily needs outcomes after treatment or changes over time. Such follow-up primary results are not reported in the registry record, so the posted baseline endpoint cannot answer whether the groups’ pain changed differently.

7. Results Posted in the Registry

• NSAID: mean 45.20 versus 47.30 on control; difference -2.10 (95% CI -10.89 to 6.69), standardized effect d = -0.10; z-test p = 0.640.

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.

Oswestry Disability Index

• 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:
  • NSAID: mean 29.40 versus 28.90 on control; difference 0.50 (95% CI -5.35 to 6.35), standardized effect d = 0.04; z-test p = 0.867.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NSAID and the control. The interval gives the range of effects that remain compatible with the data.

Roland-Morris Questionnaire

• 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:
  • NSAID: mean 7.70 versus 6.90 on control; difference 0.80 (95% CI -1.19 to 2.79), standardized effect d = 0.17; z-test p = 0.432.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NSAID and the control. The interval gives the range of effects that remain compatible with the data.

Quality of Life, Change in Health

• 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:
  • NSAID: mean 54.50 versus 52.60 on control; difference 1.90 (95% CI -4.44 to 8.24), standardized effect d = 0.12; z-test p = 0.557.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NSAID and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover disability, function and quality of life, including the Oswestry Disability Index, the Roland-Morris Questionnaire, and Quality of Life, Change in Health. Each reported summary is marked “At the beginning.” Across these measures, the mean-difference confidence intervals include zero. The unadjusted p-values do not indicate a clear baseline separation between groups on the posted measures.

This overall pattern is consistent with the primary outcome’s role as a baseline comparison: the posted summaries describe starting scores, not comparative improvement during follow-up. They can offer context about the groups’ recorded baseline status, but they do not show whether exercise and NSAID treatment produced different subsequent trajectories. Follow-up secondary estimates are not reported in the registry record.

Secondary outcomes also raise a multiplicity issue. When many outcomes are examined, some apparently unusual results can occur even when there is no underlying difference, simply because many comparisons are being considered. The posted secondary p-values are unadjusted, and no multiplicity procedure is reported in the registry record. They therefore carry less confirmatory weight than results from a prespecified primary analysis with an appropriate approach to multiple testing.

The registry lists 62 outcome measures and 58 secondary outcomes as posted. It does not report which outcomes, time points, or comparisons were designated in advance for inferential testing, or how missing secondary measurements were handled. Because the posted results are baseline summaries and no adjusted secondary analyses are reported, the most defensible reading is descriptive: the measures provide information about starting scores, but they do not establish treatment-related differences in disability, function, or quality of life.

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

• Oswestry Disability Index
• Oswestry Disability Index
• Oswestry Disability Index
• Oswestry Disability Index
• Roland-Morris Questionnaire
• Roland-Morris Questionnaire
• Roland-Morris Questionnaire
• Roland-Morris Questionnaire

9. Statistical Interpretation

10. Statistical Methods Explained

The principal posted summaries are means and standard deviations for continuous outcomes. A mean describes the arithmetic average score in a group. A standard deviation describes how dispersed individual scores are around that group average; it is not a confidence interval and does not describe uncertainty in the mean by itself. The registry reports the primary pain outcome and the posted secondary outcomes in this format.

What does a mean difference represent?

The comparison is a mean difference, with the exercise group used as the reference and NSAID as the other group. For the primary result, the posted estimate is -2.1. The direction indicates that the NSAID group’s baseline mean was lower than the exercise group’s baseline mean. The estimate compares group averages, not individual participants, and it does not show how much any participant changed. Because the timeframe is “At the beginning,” it is a starting-score contrast rather than an estimate of treatment-related change.

A mean difference is useful because it retains the outcome’s original scale units. Its interpretation depends on the scale and on the timing of measurement. The registry defines the pain scale’s endpoints, but does not report a threshold for a clinically important difference. It also does not report follow-up means or change scores for this primary outcome. Thus, the sign and size of this baseline estimate should not be translated into a claim about comparative benefit.

How should the confidence interval be understood?

In general, a confidence interval describes uncertainty around an estimate under the statistical method used. It is a range of values that are reasonably compatible with the data and model; it does not assign a probability to a particular fixed value being true. The posted primary interval runs from -10.89 to 6.694. Because zero lies within it, the registry’s estimate does not distinguish the baseline group means clearly from equality at the conventional level suggested by that interval. The interval also permits values on either side of zero, so it does not settle which group had the higher underlying mean.

The calculation method used for the posted confidence interval is not reported in the registry record. The comparison includes a standard deviation pooled across groups and group-specific standard errors, but the record does not describe the inferential model or any covariate adjustment. These details matter when interpreting precision and assumptions, and should not be inferred from the summary numbers alone.

What does the p-value add?

The primary unadjusted p-value is 0.64. In general, a p-value evaluates compatibility between the observed data and a specified null model, conditional on the test’s assumptions. It is not a measure of effect magnitude, does not express the probability that the result arose by chance, and does not indicate the probability that one treatment is better. The exact test used to obtain the posted p-value is not reported in the registry record. Since the comparison is at baseline, the p-value concerns a starting-score contrast, not a treatment effect.

The label “unadjusted” is important because the record includes multiple outcomes. A p-value considered without accounting for the number of comparisons can overstate how persuasive a collection of isolated results is. No multiplicity adjustment is reported in the registry record. The posted secondary results should therefore be treated as descriptive or exploratory rather than as a set of confirmatory tests.

What do standardized effects and standard deviations tell us?

The posted comparisons also include standardized effect estimates and pooled standard deviations. In general, a standardized effect expresses a difference relative to the spread of scores, which can help compare outcomes measured on different scales. It is not a substitute for the original-scale difference: readers still need the outcome’s direction, units, timing, and a meaningful clinical context. The registry does not report a clinical-importance threshold for these measures.

Standard deviations describe variability among participants. Standard errors, by contrast, describe uncertainty in an estimated mean. The posted record reports group-specific standard errors as well as standard deviations. In general, standard errors are used in estimating uncertainty, while standard deviations help describe the distribution of observed scores. Neither quantity by itself resolves possible selection, measurement, missing-data, or analysis-population issues.

The record identifies the allocation as randomized and the design as parallel, but the randomization procedures, the statistical analysis plan, analysis population, missing-data methods, and any adjusted analyses are not reported in the registry record. No specific model, interim-analysis procedure, or sample-size justification for the trial’s original design is reported in the registry record. These absences limit what can be concluded about how the posted comparisons were selected and analyzed. Most importantly, no follow-up primary estimates are posted, so statistical interpretation remains limited to the baseline summaries and cannot address the trial’s stated follow-up objective.

11. Confidence Intervals and Precision

The primary mean difference is -2.1, with a 95% confidence interval from -10.89 to 6.694. In general, a confidence interval conveys the precision of an estimate by indicating the range of values compatible with the data and the method used. This interval includes zero and extends to both negative and positive values, so the baseline data leave uncertainty about the direction of the underlying mean difference. The point estimate alone should not be treated as a precise description of the groups’ difference.

The interval applies to the baseline comparison, not to a change after treatment. Its width is relevant when asking how precisely the starting means differ, but it does not quantify the precision of a follow-up treatment effect. No follow-up confidence interval for the primary outcome is reported in the registry record.

Statistical precision and clinical importance are distinct. A narrow interval can be precise without establishing that an effect matters to patients; a wider interval may leave a range of potentially relevant values unresolved. The registry does not report a threshold for a clinically important difference on the pain scale. Thus, the posted interval can be described statistically, but the record does not support labeling any part of its range clinically important or unimportant.

The confidence interval’s calculation procedure and assumptions are not reported in the registry record. As with any interval, interpretation depends on the model and data quality, including how missing observations were handled. Those details are also not reported. The interval should therefore be read as the registry’s stated uncertainty around the baseline mean difference, not as a complete account of uncertainty in the trial’s longitudinal question.

12. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm, not total events. They are illustrations based on the posted observed effect, rather than the trial’s original design calculation. The registry record does not report the trial’s own sample-size assumptions or justification.

The planning illustration uses 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: 100% of the observed effect, 75% of the observed effect, or 50% of the observed effect. The figures are given separately for 80% power and 90% power.

In general, power is the chance that a study will detect an effect of a specified size under the assumed model and design, if that effect is present. The 80% column gives the planned participants per arm for an illustration with 80% power; the 90% column gives the planned participants per arm for an illustration with 90% power. Higher target power generally requires more participants under otherwise fixed assumptions.

The rows that plan for a smaller fraction of the observed effect require more participants per arm. Smaller effects are harder to distinguish from random variation, so a larger study is needed to achieve the same target power under the stated assumptions. These figures are not observed power. They are planning illustrations, and they do not show that the completed trial had a particular probability of detecting an effect or that it was designed using these assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.100; pooled standard deviation σ = 21.214.
2. n = 2 × (1.96 + 0.842)² × 21.214² / -2.100² = 1,602.0, rounded up to 1,602 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2.09999999999999                      # observed difference in means
sigma <- 21.2144033404409                     # 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(1374269)
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 = 1,602 (80% power), 2,145 (90% power)
 75% of observed effect: n per arm = 2,848 (80% power), 3,813 (90% power)
 50% of observed effect: n per arm = 6,408 (80% power), 8,579 (90% power)
power.t.test: 1603 
Simulated power at n = 1,602 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. Multiplicity, Missing Data and Analysis Populations

The record includes multiple outcome measures, including repeated listings of the Oswestry Disability Index and Roland-Morris Questionnaire among secondary outcomes. It reports 62 outcome measures and 58 secondary outcomes as posted. With many outcomes or time points, the chance of finding an apparently notable result among unadjusted comparisons can increase. In general, a prespecified multiplicity strategy can help control the interpretation of a family of tests. No multiplicity adjustment or hierarchy of confirmatory outcomes is reported in the registry record.

The primary comparison is reported with an unadjusted p-value. The posted secondary comparisons also report unadjusted p-values, and the record does not give a family-wise error approach, false-discovery approach, or other correction. The exact analysis plan and which analyses were prespecified are not reported in the registry record. This limits the ability to distinguish planned confirmatory results from exploratory analyses. It also means isolated secondary p-values should not be treated as definitive evidence, particularly when the results are all recorded at the beginning rather than at follow-up.

Missing-data handling is not reported in the registry record. The listed arm sizes describe the participants summarized for the outcomes, but the record does not explain whether all enrolled participants contributed to every measure, how missing measurements were handled, or whether any imputation was used. The analysis population, including whether an intention-to-treat or per-protocol approach was used, is not reported in the registry record.

These omissions do not establish that missing data or multiplicity problems occurred. They mean that readers cannot assess their possible effects from the registry entry. The record also does not report interim analyses, stopping rules, or a statistical analysis plan. In addition, the displayed outcome timeframes are at the beginning, while the trial description states a 6-months follow-up objective. Follow-up results and their missing-data accounting are not reported in the registry record, preventing assessment of the planned longitudinal comparison.

15. 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 5% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event figures report 0 affected participants among 46 at risk in the exercise group and 0 among 44 at risk in the NSAID group. The registry lists no serious adverse event terms. These are counts recorded in the entry; they should not be taken as proof that serious events could not occur or that the groups had equivalent safety.

For other, non-serious adverse events, the record reports 0 affected participants among 46 at risk in the exercise group and 14 among 44 at risk in the NSAID group. These counts are distinct from the serious-event counts. The registry record does not provide event descriptions, severity breakdowns, timing, exposure-adjusted rates, or details of how adverse events were collected and classified. Deaths are not reported in the registry record.

Without follow-up duration by participant, event definitions, completeness of reporting, and methods for comparing adverse events, the counts are descriptive rather than a complete comparative safety analysis. They should be interpreted alongside the limits of the registry’s reporting, not as a recommendation about either treatment.

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

The registry describes a randomized trial intended to compare an exercise program with NSAID treatment for people with subacute low back pain and to assess pain, function and quality of life during follow-up. The posted primary result, however, is a baseline pain-score comparison. The mean difference is -2.1, with a 95% confidence interval from -10.89 to 6.694 and an unadjusted p-value of 0.64. These figures describe the recorded starting scores and their uncertainty; they do not establish how either group changed after treatment.

The trial’s stated purpose and the timeframe of the posted results are not the same. A baseline comparison can show whether the groups started at similar recorded levels on an outcome, but it cannot answer whether one group improved more, whether any change lasted, or whether treatment altered function or quality of life. Follow-up outcome estimates are not reported in the registry record. For that reason, conclusions about comparative effectiveness cannot be drawn from the posted outcome results.

The same limitation applies to the secondary measures. Their posted summaries are also at the beginning, and the record does not report follow-up comparisons. Their unadjusted p-values must also be read in light of the multiple outcomes and the absence of a reported multiplicity plan. The adverse-event counts describe what the registry records but lack the detail needed to assess rates, event types, or comparative safety fully.

More broadly, a nonsignificant p-value is not proof that two groups are identical, just as a numerical difference does not by itself establish a meaningful effect. Confidence intervals convey uncertainty, but the record does not identify a clinically important threshold for these outcomes. The results therefore support a limited statistical description of baseline scores and adverse-event counts. They do not show that either treatment works or fails, and they do not support medical advice.

17. Why This Trial Matters Statistically

This trial is statistically instructive because its stated objective concerns change over follow-up, while the posted outcome summaries are all marked “At the beginning.” Correctly distinguishing baseline status from a treatment effect is fundamental to interpreting randomized trials. A randomized design does not make a baseline contrast into an estimate of improvement; treatment effects require relevant outcomes after assignment or a suitable comparison of change.

The primary pain result also illustrates why an estimate, confidence interval and p-value should be read together. The point estimate is -2.1, the interval extends from -10.89 to 6.694, and the unadjusted p-value is 0.64. The estimate gives the direction and scale of the baseline contrast, the interval conveys uncertainty, and the p-value describes compatibility with a null model under the test assumptions. None of these alone measures clinical importance, and the registry does not report a clinical-importance threshold.

The entry also highlights the importance of reporting an analysis plan, missing-data methods, analysis population, and multiplicity handling when many outcomes are posted. Without those details, readers cannot fully evaluate how the comparisons were selected or how robust they are. The secondary results are particularly important to interpret cautiously because they are unadjusted and refer to baseline scores.

Finally, the record shows why registry entries are useful but need careful reading. It records the randomized parallel-group design, interventions, outcome scales, and adverse-event counts, while important follow-up estimates and methodological details are not reported in the registry record. Recognizing both what the record documents and what it leaves unresolved prevents descriptive statistics from being mistaken for evidence of a treatment effect.

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.

A central limitation of the posted results is that the primary and secondary outcomes are all recorded at the beginning, despite the trial description’s stated 6-months follow-up objective. No follow-up estimates or changes from baseline are reported in the registry record. Consequently, the posted results do not answer the intended longitudinal comparison.

The intervention descriptions leave some practical details unclear. The exercise description includes the schedule and physiotherapist delivery, but its text is incomplete. The NSAID description allows naproxen or celecoxib and includes rescue acetaminophen; how the medication choice was made and how rescue medication use was recorded are not reported in the registry record. Treatment adherence, exposure, co-interventions, and protocol deviations are not reported in the registry record.

The registry identifies randomization and triple masking, but does not report the sequence-generation method, allocation concealment, who was masked, or how masking was maintained. The statistical analysis plan, original sample-size justification, analysis population, missing-data methods, and any covariate-adjusted analyses are also not reported. These gaps make it difficult to evaluate the planned analyses and the potential impact of incomplete outcome data.

Many outcomes are listed, yet a multiplicity strategy and outcome hierarchy are not reported. The posted secondary p-values are unadjusted, limiting their confirmatory interpretation. The adverse-event record gives counts but not event descriptions, collection procedures, follow-up exposure, or deaths; deaths are not reported in the registry record. Finally, no clinically important difference threshold is listed for the outcomes, limiting interpretation of practical importance even where estimates and intervals are available.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory) — NCT01374269.
• Registry record last updated 2014-04-29; status last verified 2014-03.
• Results first posted 2014-04-29.
• 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 record describes a completed, randomized, triple-masked, parallel-group phase 4 trial with enrollment of 90. It compares a protocolized exercise program with NSAID treatment for subacute low back pain. The primary outcome is the Visual Analogue Scale of Pain, but the posted primary and secondary results are marked “At the beginning.”

For baseline pain, the posted mean difference for NSAID compared with exercise is -2.1, with a 95% confidence interval from -10.89 to 6.694 and an unadjusted p-value of 0.64. Follow-up outcome estimates, the original sample-size justification, analysis plan, missing-data methods, and multiplicity approach are not reported in the registry record. The posted results describe baseline scores and adverse-event counts, not comparative changes during follow-up.