Chiropractic Manipulation and Medical Care for Low Back Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Chiropractic Manipulation and Medical Care for Low Back Pain (NCT01211613), a randomized na study. The primary outcome is Oswestry Low Back Pain Disability Index.

2. Clinical Question

The registry record describes a comparison of three approaches for patients with recent-onset low back pain: manual chiropractic manipulation, mechanically assisted chiropractic manipulation, and standard medical care. The primary question concerns change in self-reported disability from baseline to 4 weeks after treatment, measured with the Oswestry Low Back Pain Disability Index. A secondary question concerns change in pain rating over the same timeframe.

The manual approach used a high-velocity, low-amplitude thrust applied to the lumbar spine by a doctor of chiropractic. The mechanically assisted approach used a thrust delivered with an Activator IV instrument. Standard medical care involved an examination by a physician board certified in physical medicine and rehabilitation, medical monitoring over 4 weeks, and a prescription for over-the-counter anti-inflammatory medication.

The central statistical comparison is whether the average changes in these scores differed among the randomized groups. Negative changes in the Oswestry score represent a decrease in reported disability because the scale describes higher scores as greater impairment. The registry record does not report detailed eligibility criteria, so the precise clinical population beyond recent-onset low back pain is not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group trial with single masking. The registry record lists an enrollment of 107 and three groups: manual manipulation, mechanical manipulation, and standard medical care. It does not identify who was masked, so that detail is not reported in the registry record. The trial phase is listed as not applicable.

The record gives a start date of 2010-11, a primary completion date of 2013-03, and a completed status. The sponsor was the University of Pittsburgh. The manual and mechanical interventions were delivered by a doctor of chiropractic; the mechanical approach used the Activator IV instrument. The standard-care group received physician examinations and medical monitoring over 4 weeks, as well as a prescription for over-the-counter anti-inflammatory medication.

The primary outcome was change in the Oswestry Low Back Pain Disability Index from baseline to 4 weeks after treatment. The secondary outcome was the Numeric Pain Rating Score, also assessed at 4 weeks after treatment. The posted group summaries include 37 participants for manual manipulation, 35 for mechanical manipulation, and 35 for standard medical care. The registry record does not report why these outcome counts differ from the enrollment entry, whether all randomized participants were included in the analyses, or how missing outcome data were handled.

Although the record identifies a randomized design, it does not report the randomization sequence method, allocation concealment procedures, or the details of the masking process. The original sample-size rationale and planned analysis details are also not reported in the registry record. These gaps limit assessment of how the trial was planned and how closely the reported analyses followed that plan.

4. Participant Flow and Accounting

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

Before assignment: 197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.

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 Oswestry Low Back Pain Disability Index, measured over 4 weeks (post treatment).

The primary endpoint is change in the Oswestry Low Back Pain Disability Index from baseline to 4 weeks after treatment. This questionnaire asks about activity-related impairment associated with low back pain. It contains 10 items, each rated on a Likert scale from 0 to 5. The possible total is converted to a percentage from 0 to 100, where 0 means no impairment and 100 means complete impairment.

The endpoint is reported as a mean change, with a standard deviation describing variation among participants. A negative mean change indicates that the score decreased from baseline; under the scale description, that corresponds to a decrease in self-reported disability. The group means were -16.0 for manual manipulation, -8.9 for mechanical manipulation, and -9.5 for standard medical care.

Change scores are useful because they describe how participants’ measured scores shifted over the specified follow-up period, rather than only describing an endpoint value. Comparing average changes can help assess whether the observed shift differed across randomized groups. However, the registry record does not report the baseline group means or the full analysis details, so the posted summaries alone cannot establish how baseline values were handled in the sponsor’s regression analysis.

The index measures self-reported impairment; it does not directly measure every aspect of low back pain or function. The results therefore apply to this defined score and follow-up timeframe, rather than to all possible outcomes or later periods.

7. Results Posted in the Registry

• Manual Manipulation: mean -16.00 versus -9.50 on control; difference -6.50 (95% CI -13.09 to 0.09), standardized effect d = -0.46; z-test p = 0.053.
• Mechanical Manipulation: mean -8.90 versus -9.50 on control; difference 0.60 (95% CI -5.59 to 6.79), standardized effect d = 0.05; z-test p = 0.849.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Numeric Pain Rating Score.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Manual Manipulation: mean -3.70 versus -1.90 on control; difference -1.80 (95% CI -2.67 to -0.93), standardized effect d = -0.96; z-test p = <0.001.
  • Mechanical Manipulation: mean -2.60 versus -1.90 on control; difference -0.70 (95% CI -1.60 to 0.20), standardized effect d = -0.36; z-test p = 0.128.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Manual Manipulation 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 Mechanical Manipulation and the control. The interval gives the range of effects that remain compatible with the data.

The registry record identifies one secondary outcome: the Numeric Pain Rating Score at 4 weeks after treatment. Mean changes were negative in all three groups. The posted pairwise recalculation shows a more negative mean change for manual manipulation than for standard medical care, while the mechanical-manipulation estimate is closer to the standard-care change. These comparisons form a pattern that is not identical to the primary disability outcome.

The secondary outcome does not replace or resolve the primary result. Pain rating and disability measure related but distinct aspects of low back pain, and a difference on one measure need not imply a corresponding difference on the other. The registry record reports an overall linear-regression p-value of 0.002 for the secondary outcome, but does not give an estimate, confidence interval, or further model details for that analysis. The re-calculated pairwise comparisons are unadjusted and should be considered in that context.

Unadjusted secondary results carry less weight because multiple outcomes and comparisons create more opportunities for a result to appear notable by chance. The registry record does not report a multiplicity adjustment or a prespecified hierarchy governing how secondary tests should be interpreted. The secondary findings are therefore best treated as additional evidence about the measured pain score, rather than as independent confirmation of the primary outcome or as a basis for broad conclusions.

In general, consistency across outcomes can add context, but differences in measurement, analysis, and uncertainty matter. Here the sponsor’s overall p-value and the pairwise re-calculations are not interchangeable, and the record does not supply enough detail to reconcile them. Interpretation should remain limited to the posted outcome summaries and analyses.

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

• Numeric Pain Rating Score.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary and secondary measures are continuous outcomes summarized by group means and standard deviations. A mean describes the average observed change, while the standard deviation describes how spread out individual changes are around that average. A group mean alone does not show how consistent the individual responses were; the spread and uncertainty around a comparison matter as well.

The posted re-calculations compare each manipulation group with standard medical care using a difference in group means. For the primary endpoint, the difference is based on the change-score means. A negative estimated difference means the manipulation group had a more negative average change than standard medical care under the reported subtraction order. This numerical direction does not, by itself, establish that the difference is reliable or clinically important.

Each re-calculated comparison includes a confidence interval and an unadjusted p-value. A confidence interval gives a range of effect estimates compatible with the observed data under the calculation’s assumptions. If an interval for a mean difference includes zero, the data are compatible with no average difference as well as with differences in either direction. A p-value describes how unusual the data would be under a specified null hypothesis and model; it is not the probability that the null hypothesis is true.

The re-calculations use pooled standard deviations and standard errors from the posted summaries. They are unadjusted comparisons: they do not account for covariates, do not reproduce the sponsor’s regression model, and do not appear to adjust for the multiple comparisons across outcomes and groups. Their role is to provide a transparent comparison based on the available summary statistics, not to reconstruct the complete trial analysis.

The sponsor reports a linear regression analysis involving all three groups for the primary outcome and reports p = 0.009. A regression can compare groups while accounting for variables included in the model, but the registry record does not report which covariates, coding choices, or other modeling details were used. The reported analysis is described as a mean difference in final values, whereas the posted group summaries and re-calculated comparisons concern change from baseline. Without more detail, the two results cannot be treated as analyses of precisely the same estimand. Because the record flags a discrepancy, the sponsor’s own analysis takes precedence.

In general, random allocation is intended to make treatment groups comparable on average, including on factors that may not be measured. It does not guarantee exact balance in a particular trial, especially when group sizes are limited. Adjusted and unadjusted analyses may consequently differ. Whether adjustment is appropriate depends on the prespecified analysis plan and the variables measured; that plan is not reported in the registry record.

In general, over-dispersion means that observed variability is greater than a model assumes. A model that understates variability can produce standard errors that are too small and intervals that are too narrow. The posted outcomes are continuous and include group standard deviations, but the registry record does not describe a model-based dispersion assessment. There is therefore no basis to claim that over-dispersion was present or that any specific correction was used.

Multiplicity arises when several hypotheses are tested. Testing multiple group contrasts or outcomes increases the chance that at least one result appears statistically notable by chance if no adjustment or prespecified hierarchy is used. The registry record lists a primary outcome, a secondary pain outcome, and sponsor analyses, but does not report a multiplicity procedure or a hierarchy for interpreting tests. The re-calculated p-values are explicitly unadjusted.

All of these methods depend on the quality and completeness of the underlying observations. The registry record does not report the analysis population, missing-data approach, participant flow, or whether analyses followed intention-to-treat principles. Those omissions make it difficult to assess how missing outcomes or departures from assigned treatment may have affected the reported estimates.

11. Confidence Intervals and Precision

Precision is reflected in the range of estimates compatible with the data, not only in the point estimate or p-value. For the primary manual-versus-standard-care comparison, the re-calculated mean difference was -6.5, and its 95% confidence interval crossed zero. The corresponding unadjusted p-value was 0.053. This interval is consistent with a range of possible differences that includes little or no average contrast, as well as a larger contrast in the direction of the point estimate.

For mechanical manipulation versus standard medical care, the re-calculated mean difference was 0.6, and its confidence interval also crossed zero. The unadjusted p-value was 0.849. The estimate is close to zero, but a point estimate close to zero is not proof that the groups are equivalent. Demonstrating equivalence would require an appropriate prespecified margin and analysis, which are not reported in the registry record.

Confidence intervals convey uncertainty under the assumptions of the calculation. They do not account automatically for selection bias, missing outcomes, analysis choices, measurement limitations, or multiplicity. The re-calculated intervals arise from posted group summaries and are not the intervals from the sponsor’s regression analysis. The sponsor’s reported analysis does not include a confidence interval in the registry record, so its estimate’s precision cannot be assessed from that record.

The group standard deviations indicate variation in individual change scores, while the interval widths also depend on the amount of information in each comparison. In general, greater variability and fewer observations tend to yield less precise estimates. The posted follow-up counts and standard deviations should therefore be read alongside the mean changes, rather than treating an estimated difference as exact.

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 event counts. They are illustrative calculations based on the observed effect, not the trial’s original design assumptions. The registry record’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; each row uses the stated fraction of the observed effect as the effect to detect. The trial’s own original design assumptions are not reported in the registry record.

The 80% power column gives the estimated participants per arm under those assumptions for an 80% chance of detecting the specified effect if that effect is the true one. The 90% power column gives the corresponding estimate for a 90% chance. These are planning probabilities under a statistical model, not guarantees about a future study. For example, the primary comparison’s row using 100% of the observed effect lists 76 participants per arm for 80% power and 101 for 90% power.

The rows that plan for 75% or 50% of the observed effect represent smaller target effects. Smaller effects are harder to distinguish from random variation, so they require more participants under the same assumptions. For the primary manual-versus-standard-care comparison, planning for 50% of the observed effect lists 302 participants per arm for 80% power and 404 per arm for 90% power.

These figures are not observed power. They are planning illustrations derived from the observed effect and stated assumptions. They should not be read as proof that the completed trial was adequately or inadequately sized, because the trial’s original sample-size justification and design assumptions are not reported in the registry record.

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 = -6.500; pooled standard deviation σ = 14.247.
2. n = 2 × (1.96 + 0.842)² × 14.247² / -6.500² = 75.4, rounded up to 76 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 <- -6.5                      # observed difference in means
sigma <- 14.2465033303915                     # 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(1211613)
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 = 76 (80% power), 101 (90% power)
 75% of observed effect: n per arm = 135 (80% power), 180 (90% power)
 50% of observed effect: n per arm = 302 (80% power), 404 (90% power)
power.t.test: 76.4 
Simulated power at n = 76 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 record reports a linear regression analysis across the three primary-outcome groups, labeled “Mean Difference (Final Values),” with an estimate of 10 and p = 0.009. It does not report a confidence interval for that estimate or describe the contrast coding and model details. The reported overall analysis should not be interpreted as identical to either pairwise re-calculation.

The re-calculations use the posted group change means and standard deviations to compare each manipulation group with standard medical care. They give unadjusted p-values of 0.053 for manual manipulation and 0.849 for mechanical manipulation. The registry record flags a discrepancy between the sponsor’s analysis and these re-calculated results. In that situation, the sponsor’s own analysis takes precedence.

The difference may reflect distinct outcome definitions, model specifications, or contrast structures, but the registry record does not provide enough information to identify the reason. It would be speculative to attribute the discrepancy to any particular analysis choice. The appropriate reading is to retain the sponsor’s reported overall result as the primary reported analysis and treat the re-calculated pairwise results as supplementary checks based on summary statistics. The missing model details and interval limit assessment of the sponsor estimate’s magnitude and precision.

15. Multiplicity, Missing Data and Analysis Populations

The record includes a primary disability outcome, a secondary pain outcome, and analyses involving three groups. Multiple outcomes and group contrasts raise a multiplicity question: when many hypotheses are tested, the chance of at least one apparently notable result can increase. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a rule for treating the secondary outcome as confirmatory or exploratory.

The primary outcome is identified as primary in the registry record, which helps distinguish it from the secondary outcome. However, the record does not report whether the sponsor had a prespecified plan for pairwise comparisons, whether all planned analyses are posted, or how the overall regression result was intended to relate to individual group contrasts. The re-calculated comparisons are unadjusted, so their p-values should not be interpreted as accounting for the full set of tests.

Missing-data information is also limited. The registry record reports outcome counts by group but does not describe reasons for missing outcomes, the number of participants with missing data, imputation, or sensitivity analyses. It does not state whether the analyses included all randomized participants or only those with observed outcomes. The analysis population and handling of participants who discontinued or did not complete follow-up are not reported in the registry record.

These omissions matter because missingness can affect both the group means and the validity of comparisons, depending on why observations are unavailable. In general, an analysis restricted to observed outcomes can be biased if missingness is related to outcome or treatment assignment. No conclusion about whether such bias occurred can be drawn from the information reported.

The registry record also does not report protocol deviations, adherence to assigned treatment, or an intention-to-treat analysis. Consequently, it is not possible to assess from the posted record how closely the reported analyses preserve the randomized comparison or how multiplicity and missing data were addressed.

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 5% reporting threshold.

The safety record lists zero serious adverse events among participants at risk in each of the three groups. It also lists zero other adverse events for each group. These entries describe what is recorded for the trial; they do not establish that the interventions have no risk or that uncommon events could not occur.

The registry record does not give event descriptions because no serious-event terms are listed. Death counts are not reported in the record. It also does not provide detailed information about how adverse events were solicited, defined, monitored, or attributed to an intervention. Without those details, the zero entries should be read as the posted event counts, not as a comprehensive estimate of safety.

The groups were limited in size, and the follow-up outcome timeframe was 4 weeks. The record does not establish how informative that observation period was for events that might occur later or be uncommon. Safety interpretation should therefore remain confined to the adverse-event entries and reporting period described in the registry record.

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

The posted results describe changes in disability and pain scores over 4 weeks among participants assigned to manual manipulation, mechanically assisted manipulation, or standard medical care. Mean disability scores decreased in all three groups. The simple unadjusted re-calculations yield different pairwise estimates for the two manipulation groups, with confidence intervals that include zero. The sponsor’s reported overall regression analysis gives p = 0.009 for the primary outcome, but its estimate lacks a reported confidence interval and the analysis details are not reported in the registry record.

This evidence does not establish that one approach is superior in every relevant respect, nor does a non-significant pairwise recalculation establish equivalence. Statistical significance and clinical importance are different questions; the record does not provide a threshold for a clinically important difference. The reported outcome is self-reported disability, with pain as a secondary measure, and the follow-up is at 4 weeks after treatment.

The conclusions are limited by the discrepancy between the sponsor’s analysis and simple recalculations, incomplete reporting of the statistical plan, and missing information about analysis populations and missing data. The sponsor’s own analysis takes precedence, but its precision and contrast are difficult to interpret without the omitted details. The recalculations provide supplementary information rather than a definitive substitute.

The registry record also does not establish whether findings apply to people outside the enrolled population, to other forms of care, or to longer-term outcomes. Detailed eligibility criteria and longer-term results are not reported in the registry record. The results should therefore be understood as findings on specified scores and a specified follow-up period, not as a comprehensive evaluation of all outcomes or settings.

18. Why This Trial Matters Statistically

This trial illustrates why a reported p-value cannot be interpreted in isolation from the estimand and analysis method. The sponsor’s overall regression result and the pairwise re-calculations answer related but not demonstrably identical questions. The record’s discrepancy flag makes it especially important to distinguish the sponsor’s reported analysis from simple comparisons calculated from group summaries.

The group means describe observed average changes, while confidence intervals show uncertainty around pairwise estimates. In the primary recalculations, intervals include zero even though the sponsor reports an overall p-value of 0.009. This is not automatically a contradiction in the statistical sense: overall and pairwise tests can differ, and the analysis details are incomplete. But without those details, readers cannot determine exactly what accounts for the difference.

The trial also demonstrates the limits of planning calculations based on an observed effect. Such calculations can help illustrate how sample requirements change when the target effect is smaller, but they are not the original sample-size justification and are not observed power. The registry record does not report the original rationale, leaving uncertainty about the trial’s planned ability to estimate the effects of interest.

Finally, the study highlights the importance of complete registry reporting. Information on masking, analysis populations, missing outcomes, multiplicity, and model specification is needed to assess reliability and precision. These details are not technical extras: they affect how researchers interpret the evidence and compare it with other studies.

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 specific to this record constrain interpretation. First, there is a flagged discrepancy between the sponsor’s three-group regression analysis and the unadjusted pairwise re-calculations from the posted summaries. The sponsor’s analysis takes precedence, but the registry record does not include enough model detail or a confidence interval to assess its estimate fully.

Second, the sponsor analysis is labeled as a mean difference in final values, whereas the arm summaries and recalculations describe change from baseline. The record does not clarify the relationship between these outcome definitions or the contrast represented by the reported estimate. This limits direct comparison of the sponsor result with the pairwise results.

Third, the registry record does not report the identity of the masked party, allocation concealment, the original sample-size rationale, prespecified analysis details, or the analysis population. It also does not describe missing outcomes, reasons for missingness, or sensitivity analyses. These omissions prevent a full evaluation of how the study was conducted and analyzed.

Fourth, the posted outcomes cover 4 weeks after treatment. Longer-term outcomes are not reported in the registry record. Detailed eligibility criteria are also absent, limiting assessment of how broadly the findings may apply. The adverse-event entries report zero events but provide limited information about event ascertainment, and deaths are not reported.

Finally, the secondary endpoint and multiple group comparisons raise multiplicity concerns, while no adjustment is reported. The recalculated tests are unadjusted and based on summary statistics, so they cannot account for individual-level covariates or reproduce a more detailed regression model.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Chiropractic Manipulation and Medical Care for Low Back Pain — NCT01211613.
• Registry record last updated 2017-01-30; status last verified 2016-12.
• Results first posted 2014-11-24.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT01211613 is a completed, randomized, single-masked, parallel-group trial sponsored by the University of Pittsburgh. It compared manual chiropractic manipulation, mechanically assisted manipulation using the Activator IV instrument, and standard medical care for recent-onset low back pain. Enrollment is listed as 107.

The primary outcome was change in Oswestry Low Back Pain Disability Index from baseline to 4 weeks after treatment. The secondary outcome was change in Numeric Pain Rating Score at the same timeframe. The sponsor reported a three-group linear regression result for the primary outcome with p = 0.009. Unadjusted recalculations from posted summaries yield pairwise results with confidence intervals crossing zero; the record flags a discrepancy, so the sponsor’s analysis takes precedence.

Important details about the sponsor’s model, missing data, analysis populations, multiplicity, and original sample-size rationale are not reported in the registry record. Safety entries list zero serious and other adverse events in each group; death counts are not reported.