The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health (NCT06403098), a randomized na study. The primary outcome is Weekly Averaged Systolic Blood Pressure.

2. Clinical Question

3. Trial Design

The study is registered as a randomized, single-masked, crossover interventional study, with 30 participants listed as the enrollment. Its status is completed. The registry lists the population as healthy and the device intervention as an external nasal dilator strip. The study began on 2024-05-02, and its primary completion date is listed as 2025-06-16.

In a crossover design, participants receive or experience more than one condition, so comparisons can be made within the same study population. That general design feature can reduce the effect of stable differences between people, but the registry record does not report the condition sequence, randomization procedure, or whether each participant contributed usable data in both conditions. The arm descriptions specify 7 consecutive nights and days for each condition. They do not report a washout interval or other details about the transition between conditions.

The record identifies the study as single-masked but does not say who was masked or how masking was implemented. It describes participants measuring blood pressure and heart rate variability immediately after waking, and completing a sleep diary in the no-strip condition. The strip condition description also mentions post-waking measurements, but its text ends before completing the diary description. The full details of the data-collection procedures are therefore not reported in the registry record.

The posted primary outcome is weekly averaged systolic blood pressure. The registry also lists weekly averaged sleep efficiency and weekly averaged self-rated sleep quality as secondary outcomes. It records six outcome measures overall, but only two secondary outcomes are represented in the posted results. The registry record does not report a formal statistical analysis entry.

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: 30 participants enrolled. One participant withdrew before randomization because she lost interest. Another withdrew because she mentioned health history information which disqualified her from the study based on our inclusion and exclusion criteria.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 28 participants started data collection. Participants were excluded from the analysis if they did not complete this assessment (n=6), were sick during data collection and did not notify the study team (n=1), had a significant life event which stopped their participation (n=1), or they did not complete at least five blood pressure and heart rate variability measures during both arms of the study (n=3)

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: These numbers are for all participants randomized

6. Primary Endpoint

The registry lists the primary outcome as Weekly Averaged Systolic Blood Pressure, measured over Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions..

The primary endpoint is weekly averaged systolic blood pressure, measured immediately after waking. The registry describes brachial systolic blood pressure measured with an automated blood pressure monitor, identified as OMRON BP5250. Measurements were planned immediately after waking for 14 consecutive days, with weekly averages compared between conditions.

Systolic blood pressure is the pressure recorded during the heart’s contraction. Averaging measurements across a week can represent the pattern across repeated mornings rather than relying on a single reading. In general, repeated measurements may help reduce the influence of ordinary day-to-day fluctuation on an endpoint, although they do not remove measurement error or other sources of variation.

The endpoint is relevant to the study’s stated aim because the investigators wanted to examine immediate post-waking blood pressure alongside objective and perceived sleep measures and heart-rate variability. The registry record supplies the measurement description and timeframe, but does not report details such as the number of readings taken at each waking measurement or how weekly averages were handled when readings were missing.

The posted means are 107.0 for the no-strip condition and 106.0 for the strip condition. Their posted mean difference is -1.0. This is a descriptive comparison of the available posted data, not by itself evidence that the strip caused a change. The confidence interval and the small posted analysis groups are important when judging how precisely the comparison estimates a condition difference.

7. Results Posted in the Registry

• External Nasal Dilator Strip: mean 106.00 versus 107.00 on control; difference -1.00 (95% CI -7.09 to 5.09), standardized effect d = -0.11; z-test p = 0.747.

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.

Weekly Averaged Sleep Efficiency (%)

• 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:
  • External Nasal Dilator Strip: mean 90.00 versus 90.00 on control; difference 0.00 (95% CI -4.09 to 4.09), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between External Nasal Dilator Strip and the control. The interval gives the range of effects that remain compatible with the data.

Weekly Averaged Self-rated Sleep Quality

• 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:
  • External Nasal Dilator Strip: mean 4.00 versus 4.00 on control; difference 0.00 (95% CI -0.67 to 0.67), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between External Nasal Dilator Strip and the control. The interval gives the range of effects that remain compatible with the data.

The two posted secondary outcomes concern sleep: weekly averaged sleep efficiency and weekly averaged self-rated sleep quality. Their means are the same between the strip and no-strip conditions at the reported precision. Their posted mean differences are 0.0, with confidence intervals that include zero. The overall pattern is therefore similar to the primary result in that the posted summaries do not show a clear separation between conditions.

These outcomes add context to the study’s aim, which included objective and perceived sleep quality as well as post-waking cardiovascular measures. They do not independently resolve the uncertainty in the primary systolic blood-pressure comparison. Sleep measures describe different aspects of the study question, and a result on one outcome does not establish what happened on another. The registry record does not report a combined analysis connecting sleep outcomes with blood pressure or heart-rate variability.

The secondary results carry less weight as confirmatory evidence because the record lists no reported analysis entries and does not describe a multiplicity plan. In general, examining multiple outcomes creates more opportunities for chance findings. Prespecifying which outcomes are primary and how secondary comparisons will be interpreted can help distinguish confirmatory questions from exploratory ones. Although the registry identifies a primary outcome and lists two posted secondary outcomes, it does not report how multiplicity was addressed or whether the secondary analyses were prespecified in the statistical plan.

The registry lists six outcome measures overall, while two secondary outcomes are posted in the available results. The other outcome results and any formal analyses are not reported in the registry record. As a result, the available secondary findings should be read as descriptive and supportive context, not as a separate demonstration of a treatment effect. Their similarity to the primary result does not prove that all outcomes are unchanged, especially given the uncertainty and the limits of the analysis reporting.

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

• Weekly Averaged Sleep Efficiency (%)
• Weekly Averaged Self-rated Sleep Quality

9. Statistical Interpretation

10. Statistical Methods Explained

The registry describes a randomized crossover study. In general, randomization is intended to reduce systematic differences in how participants are assigned to conditions. A crossover design exposes participants to more than one condition, allowing a comparison that may use within-participant information. That structure can be informative, but its analysis needs to reflect the repeated observations and the order in which conditions occur. The registry record does not report the sequence, a washout period, or a statistical model for the crossover data.

What does the mean difference represent?

A mean is the arithmetic average of observed values. The posted primary means are 107.0 for no strip and 106.0 for the strip condition. The reported mean difference is -1.0, defined in the posted comparison as strip minus no strip. A negative value therefore means that the posted average was lower in the strip condition. This is a description of the comparison, not proof that the condition caused the difference. In a crossover study, interpreting that contrast also depends on how repeated measurements and the randomized sequence were handled; those analysis details are not reported in the registry record.

What does the standard deviation describe?

The registry reports standard deviations of 8.0 for no strip and 10.0 for the strip condition. In general, a standard deviation describes how spread out individual measurements are around their group mean. It is not the same as the uncertainty in the mean difference. The standard deviations give context for variation in the posted outcome values, while the confidence interval describes uncertainty around the estimated comparison. The record does not provide participant-level data, so the distribution of values and the influence of unusual observations cannot be assessed from the summaries alone.

How should the p-value be read?

The primary comparison has an unadjusted p-value of 0.747. In general, a p-value describes how unusual the observed result, or a more extreme result, would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The word unadjusted matters: the registry does not report an adjustment for multiple outcomes or other analyses. It also does not provide a formal statistical analysis entry describing the test, model, or assumptions behind the comparison.

The p-value should therefore be read alongside the estimated difference and confidence interval, rather than in isolation. The interval ranges from -7.088 to 5.088 and crosses zero. This means the results do not sharply distinguish a negative difference from no difference or a positive difference. A p-value above a conventional threshold does not demonstrate that the conditions are equivalent. The registry record does not report a threshold for statistical significance, an equivalence margin, or a prespecified analysis plan.

Why does over-dispersion matter in general?

Over-dispersion is a general issue for outcomes whose variability is greater than a model assumes. If a statistical model understates variability, its standard errors may be too small and its confidence intervals too narrow. That concern is not directly assessed by the posted summaries for this continuous endpoint. More generally, the appropriate variance model depends on the outcome and design. The registry record does not report a model or diagnostics, so there is no basis for concluding whether over-dispersion was relevant or addressed in the study analysis.

What is and is not reported about the analysis?

The registry lists zero reported analysis entries. It does post summary statistics and comparison values for the primary outcome and two secondary outcomes. These are not a substitute for a full analysis description. The registry record does not report whether the comparison was based on paired or independent observations, how repeated daily readings were aggregated when incomplete, or whether any adjustment was made for period or sequence. It also does not report an intention-to-treat definition, a per-protocol definition, or a prespecified approach to missing data.

The number of participants with posted outcome data is 17 in each condition. Because this is a crossover study, equal condition counts do not establish that the same participants contributed to both condition summaries. The record does not provide participant-level overlap or a count of complete paired observations. Those details matter because an analysis of paired observations uses information about each participant’s outcomes across conditions, whereas a comparison treating condition summaries as independent does not use that pairing in the same way.

Statistical methods can quantify uncertainty, but they cannot resolve limitations in incomplete reporting or establish that an observed association is causal. The safest reading is to distinguish the posted descriptive summaries from the analyses that are not described. The registry’s numerical comparison is informative as a summary, while the unreported design and analysis details limit assessment of how fully it reflects the crossover structure.

11. Confidence Intervals and Precision

The primary mean difference is -1.0, with a confidence interval from -7.088 to 5.088. The interval is wide enough to include zero and both negative and positive differences. It therefore indicates that the posted estimate is not precise enough to pin down the direction of a condition difference. The interval should be considered alongside the means of 107.0 and 106.0 and the standard deviations of 8.0 and 10.0.

In general, a confidence interval is a range of values compatible with the observed data under the method and assumptions used to calculate it. It describes uncertainty in an estimate; it is not a range containing a known proportion of individual measurements, and it does not assign a probability to a particular effect after the data have been observed. The registry record does not report the analysis method in sufficient detail to assess all assumptions behind this interval, particularly how the crossover design was handled.

The posted comparison has an unadjusted p-value of 0.747. The interval’s inclusion of zero is consistent with the absence of strong evidence for a difference in this comparison, but neither the p-value nor the interval establishes equivalence. The study’s posted condition groups each contain 17 participants, and the primary outcome description reports exclusions from the 28 participants who started data collection. A smaller analysis set generally leaves less information for estimating a difference, though the exact impact depends on the data and analysis.

The confidence interval is an estimate of statistical precision, not a measure of clinical importance. The registry record does not define a threshold for a clinically meaningful change in systolic blood pressure. Accordingly, the interval can be described in statistical terms, but the record does not support deciding whether all values within it would be important or unimportant in practice.

12. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm, not total events. The registry’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The calculations use the stated fraction of the observed effect as the effect to detect. The original design assumptions for the trial are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm that the planning calculation associates with an 80% chance of detecting the specified effect under its assumptions, if that effect is real. The 90% power column gives the corresponding planning number for a 90% chance. These are prospective planning quantities, not descriptions of the probability that the completed study detected an effect.

The rows vary the target effect: planning for 100% of the observed effect, planning for 75% of the observed effect, and planning for 50% of the observed effect. The listed participant requirements increase as the target effect gets smaller. In general, smaller effects are harder to distinguish from background variation, so detecting them with the same assumptions requires more participants. The posted values are illustrations based on the observed effect, rather than evidence that the original trial was designed around that effect.

These figures are not observed power. Observed power is not a useful substitute for reading the estimate and its uncertainty after a study has been completed. The confidence interval for the primary comparison communicates the uncertainty in the posted result directly. The planning figures instead show how sample-size requirements would change under the stated assumptions and chosen target effects. They do not account for any unreported features of the crossover design or establish what sample size would be appropriate for a future study.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = -1.000; pooled standard deviation σ = 9.055.
2. n = 2 × (1.96 + 0.842)² × 9.055² / -1.000² = 1,287.2, rounded up to 1,288 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1                      # observed difference in means
sigma <- 9.05538513813742                     # 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(6403098)
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 = 1,288 (80% power), 1,724 (90% power)
 75% of observed effect: n per arm = 2,289 (80% power), 3,064 (90% power)
 50% of observed effect: n per arm = 5,149 (80% power), 6,893 (90% power)
power.t.test: 1288.2 
Simulated power at n = 1,288 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 registry identifies weekly averaged systolic blood pressure as the primary outcome and lists weekly averaged sleep efficiency and weekly averaged self-rated sleep quality among the secondary outcomes. It reports six outcome measures overall, but posts results for only two secondary outcomes. The remaining outcome results are not reported in the registry record. No formal analysis entries are listed.

Multiplicity arises when several outcomes, comparisons, or analyses are considered. In general, the more opportunities there are to identify a result, the greater the chance that at least one apparently unusual finding occurs by chance. Statistical approaches can control or describe that issue, but the registry record does not report whether any multiplicity adjustment was planned or used. The posted p-values are described as unadjusted, so they should not be treated as accounting for a family of outcomes.

The primary outcome’s population description says 28 participants started data collection and identifies exclusions for not completing the assessment (n=6), illness during data collection without notifying the study team (n=1), and a significant life event that stopped participation (n=1). It begins another exclusion reason, but the full wording is not reported in the registry record. The posted primary analysis has 17 participants in each condition. The record does not explain all transitions from those who started data collection to the posted analysis groups, or report the number with complete paired data.

Missing-data methods are not reported. In general, excluding participants with incomplete measurements can affect an estimate if the reasons for missingness are related to the outcomes or condition. The record does not say whether missing values were imputed, whether analyses used only complete cases, or whether sensitivity analyses were conducted. It also does not report intention-to-treat or per-protocol analysis populations. These omissions limit assessment of the potential effects of missing data and the robustness of the posted comparisons.

The registry record also does not give the original statistical analysis plan, detailed model specification, or handling of condition sequence and period. These are particularly relevant for a crossover design. The available summaries can be described, but the record does not provide enough information to verify the analysis choices or evaluate whether all planned outcomes and participants were handled as intended.

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 registry reports serious adverse events for the no-strip condition among 28 participants at risk: 0 serious events were reported. For the external nasal dilator strip condition, 28 participants were listed as at risk and 0 serious events were reported. The record also lists 0 deaths in each condition. The adverse-event summary reports 0 other adverse events in each condition among those listed as at risk.

These figures describe what was reported in the registry record; they do not establish that no adverse events occurred outside the record’s reporting scope, nor do they show that the conditions are equally safe. The record does not provide event descriptions because no event terms are listed among the reported serious-event terms. It also does not explain the method used to collect or attribute adverse events.

The at-risk figures are safety-reporting denominators and should not be conflated with the 17 participants per condition in the posted primary outcome summaries. Safety counts and outcome-analysis counts can differ because they may refer to different reporting populations or data completeness. The adverse-event figures are therefore best read as a compact registry report, not as a complete assessment of safety or as evidence that risk is absent.

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

The posted primary comparison shows weekly averaged systolic blood pressure means of 107.0 without a strip and 106.0 with an external nasal dilator strip. The estimated mean difference is -1.0, and the confidence interval ranges from -7.088 to 5.088. The unadjusted p-value is 0.747. These statistics describe the posted data and indicate substantial uncertainty about the size and direction of a condition difference.

The result does not establish that wearing a strip changes systolic blood pressure, nor does it establish that the conditions are equivalent. A lack of strong statistical evidence for a difference is not proof of no effect. The registry record does not specify a clinically meaningful threshold, so it cannot show whether the possible differences represented by the interval would matter clinically.

The study’s stated aim also includes objective and perceived sleep quality, immediate post-waking heart rate variability, and cardiovascular health. The posted results include two sleep outcomes, but do not provide posted results for every listed outcome measure. The registry record does not report heart-rate-variability results or a broader cardiovascular analysis. The available blood-pressure and sleep summaries therefore do not answer every part of the stated study aim.

The study is described as randomized and crossover, but the registry does not report enough detail to assess the condition sequence, washout, paired analysis, period effects, or missing-data approach. These omissions matter when interpreting a crossover comparison. The posted analysis groups contain 17 participants in each condition, while the primary outcome description reports 28 participants started data collection and identifies exclusions. That difference in reported analysis population further limits how broadly the summaries can be interpreted.

Overall, the registry record offers descriptive comparisons with uncertainty, not a definitive causal or clinical conclusion. The findings apply to the posted data and should not be generalized beyond the studied healthy population on the basis of this record alone.

17. Why This Trial Matters Statistically

This trial is statistically interesting because its randomized crossover design raises an important distinction between comparing separate groups and comparing repeated observations from the same participants. In general, crossover studies can use within-person comparisons to reduce the influence of stable individual differences. That advantage depends on appropriate design and analysis details, including sequence, timing, and how repeated measurements are modeled. Those details are not reported in the registry record, so readers cannot verify how the posted comparison reflects the crossover structure.

The primary result also illustrates why an estimated difference, its confidence interval, and a p-value should be read together. The posted means are close, but the confidence interval ranges from -7.088 to 5.088. The unadjusted p-value of 0.747 is not proof that the conditions are identical. The interval communicates that the estimate remains uncertain, while the absence of a reported clinically meaningful threshold prevents a judgment about the practical importance of values within that interval.

Another statistical issue is the gap between the number who started data collection and the posted analysis groups. The primary outcome description reports 28 starts and several exclusions, while 17 participants are represented in each condition summary. Incomplete reporting of the final exclusion reason and missing-data handling makes it harder to assess selection effects and the analysis population.

Finally, the record lists multiple outcomes but no formal analysis entries or multiplicity plan. The primary and secondary results can be described, but confirmatory interpretation is limited when the analysis strategy is not documented. These issues make the study useful as an example of how design, reporting, uncertainty, and outcome multiplicity shape interpretation—not merely how close two means appear.

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 registry record leaves several trial-specific details unclear. Although the study is labeled randomized, single-masked, and crossover, it does not describe the randomization sequence, who was masked, how masking was implemented, or the order in which conditions occurred. The condition descriptions specify 7 consecutive nights and days for each condition, but a washout interval is not reported. Without these details, readers cannot assess possible sequence or period effects.

The posted primary outcome summaries give 17 participants in each condition, but the record does not say whether these are the same participants in both conditions or how many contributed a complete pair of condition measurements. This matters for interpreting a crossover comparison. The analysis method and any adjustment for within-participant correlation are not reported, and the registry lists no formal analysis entries.

The primary outcome population description says 28 participants started data collection and names multiple exclusion reasons. Its final exclusion wording is incomplete in the registry record. The record also does not report the handling of missing daily measurements, whether missing values were imputed, or whether sensitivity analyses were performed. These gaps restrict assessment of the impact of incomplete data.

Only two secondary outcomes are represented in the posted results despite six outcome measures being listed overall. The other outcome results are not reported in the registry record. The registry also does not state whether multiplicity was addressed, or provide a clinically meaningful threshold for the primary outcome. These are limitations of the available record and do not establish what may have been included in study documents not reported in the registry.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health — NCT06403098.
• Registry record last updated 2026-09-09; status last verified 2026-07.
• Results first posted 2026-09-09.
• 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 identifies a completed randomized, single-masked crossover study of an external nasal dilator strip in healthy participants. Enrollment is listed as 30. Each condition was scheduled for 7 consecutive nights and days, and the primary outcome was weekly averaged systolic blood pressure measured immediately after waking across 14 consecutive days.

The posted primary means were 107.0 without a strip and 106.0 with a strip. The mean difference was -1.0, with a confidence interval from -7.088 to 5.088 and an unadjusted p-value of 0.747. The posted secondary results cover weekly averaged sleep efficiency and self-rated sleep quality. The registry reports no formal analysis entries and does not fully describe the crossover analysis or missing-data methods.

The safety summary lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each condition. These are registry-reported counts and do not by themselves establish absence of risk.