Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults (NCT06739876), a randomized na study. The primary outcome is Changes in Physical Activity.

2. Clinical Question

The trial also asked whether device use and social-media support were associated with changes in sedentary behavior. Its stated rationale was to examine whether a wearable device and social-media-based intention could increase physical activity and enhance sleep quality among adults. The posted outcomes described in these results concern physical activity and sedentary behavior; sleep-quality results are not reported in the registry record.

The comparison of device plus motivational support against control addresses the combined intervention package. The comparison of device alone against control addresses device use without the added support. These two comparisons do not by themselves isolate the effect of motivational support from device use; that would require a direct comparison of the two intervention groups. A separate result for that direct comparison is not reported in the registry record.

3. Trial Design

The registry record identifies this as a completed, randomized, parallel-group trial. The listed enrollment is 75. The three groups are no wearable device, wearable device with motivational support via social media, and wearable device without support. The posted arm results list 25 participants in each group. The registry records the phase as NA.

Participants in both intervention groups were to wear a Garmin tracker for a month. The group receiving motivational support was also to receive that support via social media. The control group was not to wear the device except during baseline, post-intervention, and follow-up assessments. The record lists single masking, but who was masked and how masking was implemented are not reported in the registry record.

The primary outcome is titled Changes in Physical Activity and is expressed in steps/day. It was scheduled for assessment at baseline, immediately after the intervention, and at one month follow-up. The description says physical activity would be assessed by a self-report measure of sedentary breaks and behavior developed by the investigator in a previous study, and by device-measured physical-activity parameters from the Garmin monitor. The specific measure and the way these sources were combined for the posted outcome are not reported in the registry record.

Changes in Sedentary Behavior is listed as a secondary outcome, measured in hours / day, over the same stated time points. The record lists two outcome measures. Although it describes the trial as completed, details about adherence, withdrawals, missing observations, and the timing of the posted means relative to the planned assessment points are not reported in the registry record. The registry record states that all enrolled participants were included in the analysis, but does not explain how missing measurements, if any, were handled.

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: Eligible participants provided informed consent prior to participation. Baseline information, including demographic characteristics, physical activity levels, and sleep quality measures, was collected before group assignment. Participants were then assigned to the intervention or control group according to the study design.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All enrolled participants were included in the analysis.

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 analysis population includes all 75 participants who were randomized into the three study arms (Arm 1, Arm 2, and Arm 3) at baseline. An Intention-to-Treat (ITT) approach was employed, ensuring that all randomized individuals were accounted for in the primary and secondary outcome evaluations to minimize bias.

6. Primary Endpoint

The registry lists the primary outcome as Changes in Physical Activity, measured over Baseline, and post-assessment (immediately after the intervention), one month follow-up.

The primary endpoint is titled Changes in Physical Activity and uses steps/day as its unit. Physical activity is relevant to the trial’s stated question because the intervention combines a wearable tracker with, in one group, motivational support through social media. A step-based measure can describe daily movement in a form that is directly related to the device’s monitoring role. The registry record also describes a self-report measure of sedentary breaks and behavior, so the intended assessment was not limited to a single data source.

The outcome was scheduled at baseline, immediately after the intervention, and one month follow-up. Repeated assessment can describe activity at different stages of participation, but the posted arm-level results alone do not show each participant’s trajectory over time. The record gives group means and standard deviations and between-group mean differences, but does not report separate baseline-adjusted estimates or change-score results. It is therefore important not to interpret the posted means as a clearly documented estimate of within-person change.

The measure is useful for describing the observed group values, but the record does not fully specify the analysis method, the exact device-derived parameter used, or how self-report and device information contributed to the result. That leaves uncertainty about the precise estimand represented by the posted comparisons. Sleep quality is part of the trial’s title and rationale, but a sleep outcome result is not reported in the registry record.

7. Results Posted in the Registry

• Intervention: Device and Motivational Support Via Social Media: mean 8,096 versus 8,417 on control; difference -321.72 (95% CI -2,315 to 1,671), standardized effect d = -0.09; z-test p = 0.752.
• Intervention: Device: mean 9,498 versus 8,417 on control; difference 1,081 (95% CI -895.21 to 3,057), standardized effect d = 0.30; z-test p = 0.284.

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.

Changes in Sedentary Behavior

• 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:
  • Intervention: Device and Motivational Support Via Social Media: mean 12.34 versus 11.71 on control; difference 0.63 (95% CI -1.31 to 2.57), standardized effect d = 0.18; z-test p = 0.524.
  • Intervention: Device: mean 12.08 versus 11.71 on control; difference 0.37 (95% CI -1.68 to 2.42), standardized effect d = 0.10; z-test p = 0.723.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention: Device and Motivational Support Via Social Media and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention: Device and the control. The interval gives the range of effects that remain compatible with the data.

The listed secondary outcome is Changes in Sedentary Behavior, measured in hours / day. Both posted intervention-versus-control mean differences are positive, and both intervals include zero. This overall pattern does not provide clear evidence of a between-group difference, while the breadth of the intervals leaves uncertainty about the size and direction of the underlying effects.

The secondary results are broadly consistent with the uncertainty in the primary physical-activity comparisons: neither outcome gives a precise, conclusive separation of the intervention groups from control. That is a statement about the estimates and their uncertainty, not proof that the outcomes are identical or that the interventions have no effect. Nor does a similar pattern across outcomes establish a shared mechanism, since the outcomes measure different behaviors and their analysis details are not fully reported.

Secondary outcomes generally carry less confirmatory weight than a prespecified primary outcome, especially when their analysis plan and role in decision-making are unclear. Considering multiple outcomes and comparisons also creates a multiplicity issue: the chance of at least one apparently notable result can rise when many tests are examined without adjustment. The registry record does not report a multiplicity procedure, so the secondary results are best treated as exploratory descriptions rather than independent confirmation of the primary result.

The registry lists sleep among the conditions and refers to sleep quality in the trial’s rationale, but does not report a sleep-quality result. Sedentary behavior is the only posted secondary outcome described in the results. As a result, the secondary findings cannot answer the broader sleep-quality part of the trial’s stated motivation.

There is also no reported direct comparison between the device-only and device-plus-support groups. The two comparisons against control do not establish whether adding social-media support changes sedentary behavior. That question remains unresolved in the registry record.

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

• Changes in Sedentary Behavior

9. Statistical Interpretation

10. Statistical Methods Explained

The posted results describe continuous outcomes using group means and standard deviations. A mean is the arithmetic average of the measured values in a group; the standard deviation describes how dispersed individual measurements are around that average. The standard deviation is not the uncertainty of the mean itself. Uncertainty in the mean also depends on the number of observations and on the assumptions used to calculate an interval or test.

For each intervention group, the reported comparison is a mean difference relative to the no-device control group. A negative mean difference indicates that the intervention-group mean is lower than the control mean under the comparison’s stated direction; a positive value indicates a higher intervention-group mean. For example, the physical-activity estimate for device plus support is -321.7 steps/day, while the device-only estimate is 1081.0 steps/day. These are differences between group means, not individual changes and not direct comparisons between the two intervention groups.

A reported interval gives a range of values compatible with the data and the calculation procedure. Its width conveys precision: a wider interval leaves more uncertainty about the size and direction of the underlying difference. An interval that spans zero includes no difference among the values compatible with the estimate. This does not prove that the true difference is zero. The confidence level associated with the posted intervals is not reported in the registry record, so it should not be assigned a conventional label without that information.

The unadjusted p-value is a test statistic translated into a probability under a specified null model and its assumptions. It is not an effect size and does not tell readers whether a difference is practically important. The posted p-values are labeled unadjusted. The registry record does not report a sponsor analysis or a formal analysis plan for the comparisons, so these p-values should not be treated as results from a documented adjusted model. There are no reported analyses listed in the registry record.

For a continuous outcome, a comparison based on a mean difference is most straightforward when the observations and the analysis support a meaningful group average. The registry reports standard deviations for the arm-level outcomes, but does not provide individual-level data, distributions, or diagnostic checks. It is not possible to assess from the posted summaries whether measurements were strongly skewed, whether outliers affected the means, or whether model assumptions were evaluated.

Over-dispersion is a general concern when the observed variability is greater than a model assumes. If a method treats observations as less variable than they are, its uncertainty estimates may be too small and its intervals too narrow. Conversely, a method that accounts for greater variability can produce wider intervals. The registry record does not report an over-dispersion assessment or a model that addresses it. This is a general statistical consideration, not a claim that over-dispersion occurred in this trial.

The repeated schedule—baseline, immediately after the intervention, and one month follow-up—also matters analytically. Measurements from the same participant over time are generally related, rather than independent. A repeated-measures model or a baseline-adjusted analysis can account for aspects of that structure, but the registry record does not report whether either approach was used. The posted arm means and simple unadjusted comparisons do not, on their own, capture within-participant correlation or explain how baseline values were incorporated.

The record says all enrolled participants were included in the analysis, but the posted arm results give 25 participants per group and do not explain the handling of missing outcome measurements. An analysis population statement does not show whether every participant had complete data at every time point. The numbers contributing to each time-specific outcome, reasons for missingness, and any imputation or other missing-data procedure are not reported in the registry record.

The trial has two listed intervention comparisons for the primary endpoint, as well as a secondary endpoint. Testing multiple comparisons can increase the chance of a positive finding arising by chance if results are interpreted without accounting for multiplicity. This is a general issue; it does not imply that any particular result is false. The registry record does not report whether a multiplicity strategy was planned or applied. In consequence, the posted unadjusted p-values should be read as individual, unadjusted comparisons rather than as a family-wise conclusion.

Finally, the registry lists a randomized parallel design, but does not report the allocation sequence method, concealment procedures, the identity of the masked party, or a detailed statistical analysis plan. These omissions limit evaluation of the design and analysis beyond the information expressly recorded. They do not establish that a particular procedure was absent; such details are simply not reported in the registry record.

11. Confidence Intervals and Precision

For physical activity, the interval for device plus motivational support versus control runs from -2315.0 to 1671.0 steps/day around the estimated mean difference of -321.7 steps/day. The interval for device alone versus control runs from -895.2 to 3057.0 steps/day around the estimated mean difference of 1081.0 steps/day. Each interval includes zero and covers values on both sides of it, so the posted estimates do not tightly determine either the direction or the magnitude of a group difference.

For sedentary behavior, the device-plus-support comparison has a mean difference of 0.63 hours / day and an interval from -1.309 to 2.569. The device-only comparison has a mean difference of 0.37 hours / day and an interval from -1.679 to 2.419. These intervals also include zero and extend across a range of possible differences. The registry record does not report the confidence level used for these intervals.

Precision concerns how narrowly the data locate an estimate, not whether the estimate is important or whether a treatment is effective. The posted intervals are broad relative to their point estimates, leaving meaningful uncertainty in both direction and size. Standard deviations also show variability among the observed group values: for physical activity they range from 2708.0 to 4251.0 steps/day across groups, and for sedentary behavior from 2.87 to 4.03 hours / day. Those spreads describe observed variation, not uncertainty about a between-group effect.

The absence of a clearly reported change-score or baseline-adjusted analysis further limits interpretation of precision for change over time. The intervals and p-values are unadjusted recalculations from posted summary statistics, not sponsor-reported estimates. Thus, they are informative about the posted group summaries but should not be mistaken for a complete analysis of the scheduled repeated assessments.

12. Planning a Similar Trial: Sample Size

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

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

The 80% power column gives the estimated participants per arm for a future study to have an 80% chance of detecting the specified effect under the listed planning assumptions, if that effect is present and the assumptions hold. The 90% power column gives the corresponding planning number for a 90% chance. These are design targets for future research, not evidence about what happened in this completed trial.

The rows that plan for 75% or 50% of the observed effect consider smaller effects than the row based on 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants per arm to reach the same target power. The figures vary by outcome and comparison because the observed effects and variability differ.

These are not observed power calculations. They are planning illustrations derived from the posted effects, with assumptions that may not match a future study’s design or analysis. They should not be read as a justification for the original trial enrollment, or as a guarantee that a future trial of the indicated size will achieve its target.

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 = -321.720; pooled standard deviation σ = 3595.144.
2. n = 2 × (1.96 + 0.842)² × 3595.144² / -321.720² = 1,960.3, rounded up to 1,961 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 <- -321.719999999999                      # observed difference in means
sigma <- 3595.14417282534                     # 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(6739876)
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 = 1,961 (80% power), 2,625 (90% power)
 75% of observed effect: n per arm = 3,485 (80% power), 4,666 (90% power)
 50% of observed effect: n per arm = 7,842 (80% power), 10,497 (90% power)
power.t.test: 1961.2 
Simulated power at n = 1,961 per arm: 0.802 (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 lists a primary outcome and a secondary outcome, with each intervention group compared against control. Multiple outcome and group comparisons raise the general issue of multiplicity: if many tests are interpreted together without a prespecified strategy, the chance of at least one apparently positive result can increase. The registry record does not report a multiplicity adjustment, a testing hierarchy, or another strategy for handling this issue. The posted p-values are unadjusted and should be interpreted as such.

The record describes the primary outcome assessment at baseline, immediately after the intervention, and one month follow-up, but the posted results do not explain how measurements across these time points were analyzed. The registry does not report whether the analysis focused on a particular time point, modeled all time points jointly, or adjusted for baseline. It also does not report whether the comparisons were specified before results were examined.

The primary outcome population is described as all enrolled participants included in the analysis. However, the numbers of participants with available measurements at each assessment time, any withdrawals, and reasons for missing data are not reported in the registry record. The record does not describe an imputation method, a complete-case approach, or a sensitivity analysis for missingness. Therefore, the population statement alone is not enough to determine how incomplete measurements affected the results.

The record also does not specify whether the reported means are based on all randomized participants or only participants with observed outcome data at a particular time. The arm counts are listed as 25 per group, but time-specific denominators are not reported. The way the self-report measure and Garmin measurements contributed to the primary endpoint is likewise not fully specified.

These gaps limit assessment of whether the analyses followed a prespecified plan and how robust the estimates are to alternative handling of time, multiplicity, and missing data. They are reporting gaps, not evidence that a particular analysis or procedure was not performed.

15. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The adverse-event record lists zero serious adverse events in each of the three groups, with 25 participants at risk in each group. It also lists zero other adverse events in each group and zero deaths. These figures describe what is recorded for the listed groups; they do not by themselves establish that the interventions are free of risk.

A zero count means no event of that category was recorded in the stated group in the registry results. It does not rule out events that were not detected, not reported, or not captured under the registry’s reporting process. The record does not provide event definitions, surveillance procedures, severity details for non-serious events, or information about follow-up completeness. The serious-adverse-event terms list is empty.

The safety figures should be read alongside the outcome and design information, rather than as a stand-alone safety conclusion. The registry record does not report additional safety analyses or explain whether the observation period for adverse events covered all assessment time points. No medical recommendation follows from these counts.

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

The results describe group averages and unadjusted between-group estimates for physical activity and sedentary behavior. For the primary outcome, the point estimates favor different directions in the two intervention-versus-control comparisons, but the intervals are wide and include zero. The posted statistics therefore leave considerable uncertainty about whether the groups differed and, if so, by how much. The secondary comparisons show a similar lack of precision.

These findings do not establish that either intervention increased physical activity or improved sleep quality. Sleep-quality results are not reported in the registry record. They also do not establish that the interventions have no effect: the intervals include a range of possible differences, rather than demonstrating equivalence. A conclusion of equivalence would require an appropriate design and a prespecified margin, neither of which is reported in the registry record.

The estimates should not be read as direct evidence about the added value of social-media support. Each intervention group is compared with control, but a direct comparison between device use with and without support is not reported. Differences between two separate estimates against a common control do not substitute for a reported statistical comparison of the two intervention groups.

The trial record offers useful descriptive results from a randomized, parallel-group study, but key analytical details are missing. In particular, the timing represented by the posted means, handling of repeated observations and missing data, the analysis plan, and the confidence level for the intervals are not reported. The calculations are unadjusted recalculations based on posted summaries, so they do not replace a sponsor-reported model.

In practical terms, the posted results are inconclusive rather than definitive. They identify the estimated differences and their uncertainty, but do not establish benefit, lack of benefit, or equivalence. Any broader interpretation would need fuller outcome reporting and a clearly specified analysis of the repeated assessments.

17. Why This Trial Matters Statistically

This trial is statistically interesting because it separates two intervention components: wearing a device and receiving motivational support via social media. A three-group design can help distinguish a combined package from device use alone when comparisons are planned and reported clearly. The posted results compare each intervention group with control, but do not report the direct intervention-versus-intervention contrast needed to assess the added contribution of support.

The endpoint also involves repeated measurement over baseline, post-intervention, and follow-up. Repeated observations can offer a richer picture than a single assessment, but they require clear reporting of the time point or model behind each estimate. The registry record does not say whether the posted means represent a specific time point, a change, or a joint analysis. That makes the label Changes in Physical Activity difficult to connect precisely to the posted group means and mean differences.

The range of uncertainty is another central statistical lesson. Point estimates can differ in direction, while intervals remain compatible with no difference and with nonzero effects. Reporting estimates alongside their precision is more informative than relying on an isolated p-value. Here, the wide intervals caution against treating a non-significant result as proof of no effect or using point estimates as settled effects.

Finally, planning figures derived from observed effects illustrate how sample-size requirements depend on the effect a future study aims to detect. Smaller target effects require more participants per arm under the stated planning assumptions. Such figures are useful for understanding planning tradeoffs, but they do not recover the trial’s original rationale, which is not reported in the registry record.

18. Limitations

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

The main trial-specific limitation is that the posted outcome description and summary statistics do not fully align in a way that clarifies the estimand. The primary outcome is titled Changes in Physical Activity, but arm-level results are reported as means and standard deviations, with no separate change-score or baseline-adjusted estimates. The assessment schedule includes multiple time points, yet the reported means are not clearly tied to one time point or a model across time.

The record describes two potential sources for the primary outcome: self-report and Garmin monitor parameters. The exact measure, the particular device parameter, and how the sources were combined for the posted result are not reported in the registry record. This makes it harder to evaluate what the steps/day estimates represent and how they relate to the broader self-report assessment.

The posted comparisons are unadjusted recalculations from summary statistics, and no sponsor-reported analyses are listed. The record does not describe a repeated-measures model, baseline adjustment, multiplicity handling, or missing-data procedure. Although all enrolled participants are said to have been included in the analysis, time-specific denominators and completeness of follow-up are not reported.

The trial has three groups, but only intervention-versus-control comparisons are reported. There is no reported direct comparison of device plus support against device alone, limiting inference about the added role of social-media support. Sleep quality is prominent in the trial’s title and rationale but its outcome results are not reported in the registry record. Masking is listed as single without identifying who was masked. These reporting limitations constrain interpretation; they do not establish that the unreported procedures or outcomes were absent from the conduct of the trial.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults — NCT06739876.
• Registry record last updated 2026-04-29; status last verified 2026-04.
• Results first posted 2026-04-29.
• 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, parallel-group trial of a wearable device with or without social-media motivational support, compared with no wearable device. The listed enrollment is 75, with 25 participants reported in each group. The primary outcome is physical activity in steps/day; sedentary behavior in hours / day is listed as a secondary outcome.

The physical-activity and sedentary-behavior comparisons have intervals that include zero and leave substantial uncertainty about the direction and size of group differences. The posted comparisons are unadjusted recalculations from group summaries, and the registry record lists no sponsor-reported analyses. Results for sleep quality are not reported in the registry record.

Important details—including the analysis of repeated assessments, missing-data handling, multiplicity strategy, confidence level for the intervals, and original sample-size justification—are not reported in the registry record. The findings are descriptive and inconclusive, not evidence of equivalence or a definitive treatment effect.