A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit (NCT04253756), a randomized na study. The primary outcome is Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value.

2. Clinical Question

The clinical question is framed around the catheter used during apheresis and the resulting plasma hemoglobin measurement. The record identifies plasma exchange as the condition and names the outpatient apheresis setting in the trial title. It does not describe participant diagnoses, baseline characteristics, or the eligibility rules used to select participants, so the population represented by the results cannot be characterized more specifically from the registry record.

The study is described as randomized and as a crossover trial. A crossover design generally means that participants receive more than one intervention over time, allowing within-participant comparisons; that is a general description, not confirmation of the exact procedure used in this trial. The order of catheter use, any washout or interval between procedures, and the way repeated measurements were handled are not reported in the registry record.

The registry’s primary outcome is a comparison of mean plasma hemoglobin values by group, with a stated timeframe of 12 months. The brief summary additionally describes a hypothesis concerning pain and adverse events. The posted primary outcome does not itself provide a pain result, and the listed secondary outcome concerns return pressure >400 mmHg. Thus, the principal posted comparison addresses plasma hemoglobin rather than every aspect of the broader hypothesis described in the summary.

3. Trial Design

The registry classifies the study as randomized, with a crossover model and no masking in its design fields. The brief summary calls it a single-blinded, randomized pilot study. Those descriptions do not align fully: the design fields list masking as none, while the summary describes single blinding. The registry record does not explain which people, if any, were blinded or clarify the reason for this difference.

The two catheter conditions are the 18-gauge Autogard catheter, identified as standard of care, and the 20-gauge BD Nexiva Diffusics catheter, identified as the intervention. The trial title places the procedures in an outpatient apheresis unit. The crossover label indicates that the design was not simply a parallel-group comparison, but the registry record does not report the treatment sequence, how assignment was carried out, or whether each participant received both catheters.

The record gives an enrollment of 26. For the primary outcome, the posted arm summaries each report 13 observations. Those outcome counts should be read as the counts attached to the posted summaries; the registry does not explain how they relate to crossover periods, repeated procedures, exclusions, or the enrolled population. The brief summary describes a plan for 33 encounters in each group, with 66 encounters in total. These are stated as intended encounter counts, not the observed counts in the posted primary outcome summaries.

The study status is completed. The registry lists a start date of 2020-03-31 and a primary completion date of 2021-04-15. It characterizes the trial as a pilot intended to inform refinement and powering of a full randomized control trial. The trial’s own original design assumptions, including its statistical sample-size justification, are not reported in the registry record. Nor are sequence-specific details, the handling of periods, or the analysis population described sufficiently to reconstruct the design in full.

Although the sponsor’s posted analysis is identified as an ANOVA and a non-inferiority analysis, the record does not provide the non-inferiority margin. A label alone cannot establish the criterion used to judge non-inferiority. Interpretation therefore depends on keeping the reported analysis description separate from conclusions that would require details absent from the registry record.

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.

Overall Study

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: Due to the cross over study design, participants are represented as one Baseline group.

6. Primary Endpoint

The registry lists the primary outcome as Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value, measured over 12 months.

The primary endpoint is titled “Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value.” It is described as a comparison of mean plasma hemoglobin values by group, with g/dL as the unit and a 12-month timeframe. The record says a plasma hemoglobin test is used to assess hemolysis, described as destruction of red blood cells with release of hemoglobin into plasma. This provides the stated rationale for measuring plasma hemoglobin during apheresis.

The outcome is specified as a mean, a summary suited to a continuous measurement. The arm summaries report a mean of 16.8 for the 18G Catheter SOC group and 17.3 for the 20-gauge BD Nexiva Diffusics group. The registry also states that the test will be scored dichotomously as present or absent. That description does not clearly match the listed mean-value endpoint: a dichotomous result and a continuous value are different forms of outcome. The record does not explain whether both were collected, how the dichotomous scoring relates to the reported means, or which measure is used for the primary analysis.

Plasma hemoglobin is therefore the registry’s stated primary measure, while pain is mentioned in the brief summary rather than in the primary outcome title. The record does not post a primary pain result. The stated measure can describe the observed group means, but the registry entry alone does not establish that a particular difference represents a clinically important change, nor does it give a threshold for interpreting the measurement.

7. Results Posted in the Registry

• 20-gauge BD Nexiva Diffusics (Intervention): mean 17.30 versus 16.80 on control; difference 0.50 (95% CI -8.04 to 9.04), standardized effect d = 0.05; z-test p = 0.909.

8. Statistical Interpretation

9. Statistical Methods Explained

Several statistical ideas help distinguish the posted result from conclusions that the registry record cannot support. The primary outcome is summarized as a mean, and the posted recalculation expresses the contrast as a mean difference. The sponsor’s result is separately described as an ANOVA mean difference from final values. These are related descriptions of a comparison, but the record does not provide enough detail to show exactly how the sponsor’s model was specified.

What does a mean difference describe?

A mean is a measure of the center of a continuous distribution. A mean difference subtracts one group mean from another, with the direction depending on the order of subtraction. In this comparison, the posted estimate is defined as the intervention group minus the control group: 0.5. The positive sign therefore indicates that the intervention group’s reported mean is higher in the posted summaries. This is a descriptive direction, not a judgment that the difference is important or that one catheter is better.

The mean difference is expressed on the same measurement scale as the outcome. The primary outcome’s unit is g/dL. The record does not say what range of differences would be clinically consequential, and no such boundary should be inferred from the numerical estimate alone.

Why report standard deviations?

A standard deviation describes how spread out individual measurements are around their group mean. It is not the uncertainty interval for the mean difference. The posted standard deviations are 9.64 for the control arm and 12.4 for the intervention arm. The standard errors reported for the group means are 2.674 and 3.439, respectively. Standard errors describe the estimated sampling variability of a statistic under the calculation’s assumptions; they are not measures of the spread among individual observations.

In general, greater variability makes a group mean less precisely estimated when other features are held fixed. In a crossover study, the relationship between a participant’s measurements under the two conditions can also matter. The difference between conditions within a participant may be more or less variable than the separate measurements themselves. The registry does not report that within-participant variability or a correlation between repeated measurements, so it is not possible to assess how the crossover structure was incorporated in the posted comparison.

What does the confidence interval add?

A confidence interval gives a range of values compatible with the data and the method used to calculate it. In repeated use of a procedure under its assumptions, intervals constructed in this way have a stated coverage property. It is not a range that guarantees the true value lies within it for this particular trial. The recalculated interval for the mean difference is -8.038 to 9.038. Its breadth signals limited precision, and its inclusion of zero means the interval is compatible with no difference as well as with differences in either direction. It does not show that the groups are equivalent.

For an equivalence or non-inferiority conclusion, the interval must be compared with a clinically justified margin chosen in advance. The registry calls the sponsor analysis non-inferiority but does not report a margin. Without that criterion, the reader cannot tell from the record whether the uncertainty bounds satisfy the sponsor’s intended decision rule.

How should the p-values be understood?

The recalculated unadjusted p-value is 0.909, while the sponsor’s reported p-value is 0.87. A p-value is calculated under a statistical model and a null hypothesis; in general, it summarizes how unusual data at least as incompatible with that null would be under the model. It is not the probability that the null is true, nor is it the probability that the result is due to chance. A large p-value does not prove there is no difference, especially when the estimate is imprecise.

The difference between the two p-values may reflect different methods or assumptions, but the record does not describe enough detail to identify a cause. The recalculation is an unadjusted analysis from posted summary statistics. It does not replace the sponsor’s own analysis, which is separately reported in the registry.

What does the crossover label imply statistically?

In general, crossover designs can use comparisons within the same participant, which may control for stable participant characteristics. That advantage depends on appropriate implementation and analysis. Treatment order, time or period effects, carryover, incomplete sequences, and repeated observations can affect interpretation. The registry record does not report sequence allocation, washout procedures, period-specific results, or a model addressing these issues. Therefore, the posted arm summaries should not automatically be interpreted as an analysis that fully uses or adjusts for the crossover design.

The record lists the sponsor method as ANOVA and says the outcome parameter is mean difference from final values. It does not specify model terms, assumptions, handling of missing observations, or whether repeated measures were modeled. The registry’s “no masking” design field also differs from the brief summary’s “single blinded” description. These details limit the ability to reproduce or independently evaluate the reported analysis.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. When that happens, a model can understate uncertainty if it does not accommodate the extra variation. This is a general concept rather than a reported finding about this trial. The record supplies standard deviations for the continuous endpoint but does not report a dispersion assessment or a model diagnostic. For this mean-based outcome, the more immediate limitation is that the within-participant variation and crossover analysis are not described.

Overall, the statistical results are most appropriately read as a reported mean contrast, a broad recalculated interval, and two p-values arising from analyses that are not fully specified in the registry. They give useful descriptive information, but the missing design and model details constrain stronger inferential claims.

10. Confidence Intervals and Precision

The recalculated unadjusted mean difference is 0.5, with a 95% confidence interval from -8.038 to 9.038. The interval is wide relative to the point estimate and crosses zero. This indicates that the estimated difference is not precise enough to rule out values in either direction under the assumptions of the recalculation. The interval should be read as uncertainty around the estimated contrast, not as a range of observed individual values.

The group summaries each report 13 observations. Their means are 16.8 and 17.3, while the standard deviations are 9.64 and 12.4. The substantial spread in the observations, alongside the limited number of observations in each posted summary, is relevant to the uncertainty in a mean comparison. The registry does not report the within-participant correlation needed to understand the precision of a crossover contrast, or explain whether each summary represents participants, encounters, or another analysis unit.

The sponsor’s ANOVA result gives a mean difference of 0.5 and a p-value of 0.87, but no confidence interval is posted for that analysis. Its precision therefore cannot be assessed from the registry result using an interval. The sponsor also labels the analysis non-inferiority, but the margin is not reported. A confidence interval can support a non-inferiority interpretation only when it is evaluated against a prespecified margin; a p-value or point estimate alone does not provide that comparison.

Precision is distinct from clinical importance. Even a narrow interval would not by itself establish that a difference matters to patients, while a broad interval leaves substantial uncertainty regardless of the point estimate. The registry does not state a clinically important difference or threshold for the plasma hemoglobin measure. The posted estimate and interval therefore characterize uncertainty statistically without resolving its clinical significance.

11. 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 expressed as participants per arm for 80% power and participants per arm for 90% power. They are not total event counts. The calculation uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. These are planning assumptions for an illustration based on the observed effect; the trial’s own original design assumptions are not reported in the registry record.

The row for 100% of the observed effect gives 7,745 participants per arm for 80% power and 10,369 participants per arm for 90% power. The row for 75% of the observed effect gives 13,769 participants per arm for 80% power and 18,433 participants per arm for 90% power. The row for 50% of the observed effect gives 30,980 participants per arm for 80% power and 41,474 participants per arm for 90% power. The curve presents the same general planning relationship visually.

In plain language, the 80% column describes the planned number per arm under which the calculation would give an 80% chance of detecting the specified effect, if the assumptions and model were correct. The 90% column gives the corresponding planning target for a higher chance of detecting that effect. These are design targets, not observations from the trial. Smaller effects require more participants because they are harder to distinguish from ordinary sampling variation. The illustrations are based on the observed effect, which may itself be an imprecise estimate.

This is not observed power. It is a planning illustration and should not be read as a measurement of what the completed pilot trial achieved. The record does not report the study’s original sample-size justification, and the illustration does not establish what the crossover design would require under a model incorporating within-participant measurements.

12. 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 = 0.500; pooled standard deviation σ = 11.106.
2. n = 2 × (1.96 + 0.842)² × 11.106² / 0.500² = 7,744.9, rounded up to 7,745 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 <- 0.5                      # observed difference in means
sigma <- 11.1060704121665                     # 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(4253756)
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 = 7,745 (80% power), 10,369 (90% power)
 75% of observed effect: n per arm = 13,769 (80% power), 18,433 (90% power)
 50% of observed effect: n per arm = 30,980 (80% power), 41,474 (90% power)
power.t.test: 7745.9 
Simulated power at n = 7,745 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.

13. Analyses Reported by the Sponsor

The sponsor’s posted analysis is an ANOVA of mean difference from final values, with a reported estimate of 0.5 and p-value of 0.87. It is labeled as a non-inferiority analysis. The registry does not include a confidence interval for this result or state the non-inferiority margin, so the decision criterion and the precision of the sponsor’s estimate cannot be fully evaluated from the record.

The separate recalculation uses the posted arm summary statistics to produce an unadjusted mean difference of 0.5, a 95% confidence interval from -8.038 to 9.038, and a p-value of 0.909. It is not a reconstruction of the sponsor’s ANOVA or a crossover model. The recalculated comparison is useful as a transparent summary-based check, but it may not reflect details of the sponsor’s analysis that are not reported.

The two p-values are close but not identical. The registry marks no discrepancy, and the sponsor’s own result remains the reported trial analysis. Neither p-value alone establishes non-inferiority. A non-inferiority interpretation depends on a prespecified margin and an analysis that compares uncertainty with that margin; the margin is not reported in the registry record. The recalculation should therefore complement, not replace, the sponsor’s reported analysis.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and two analyses, and identifies one posted secondary outcome: the number of participants experiencing a return pressure >400 mmHg. The primary outcome is the comparison of mean plasma hemoglobin values. The record does not provide a complete account of all planned analyses or explain how the two posted analyses relate to the listed outcomes.

Multiplicity arises when several outcomes, comparisons, time points, or analyses are examined. In general, testing many hypotheses can increase the chance of at least one apparently notable result, unless the analysis plan accounts for this. The registry record does not report whether any multiplicity adjustment was planned or used, how outcomes were prioritized beyond the primary designation, or whether the posted analyses were prespecified. No adjustment should be assumed.

The record also does not report how missing outcome values were handled. It does not describe whether analyses used complete cases, imputation, or another approach, nor does it state the number or pattern of missing measurements. The arm summaries each report 13 observations, but the registry does not explain how those observations relate to enrollment, encounters, or the crossover periods. The enrolled population and analysis population should not be assumed to be identical.

Analysis populations are not defined in the registry record. It does not state whether the sponsor analyzed participants according to randomized assignment, treatment received, completed periods, or another rule. This matters in randomized studies, and can be particularly relevant in crossover designs where periods or treatments may be incomplete. The record also does not report how protocol deviations, crossover sequence, or repeated measurements were handled.

The brief summary says the study was intended to refine and power a full randomized control trial, but that statement does not supply the missing statistical plan. The registry record does not report an interim analysis plan, a missing-data plan, or a method for controlling multiplicity. Those omissions limit assessment of how the reported results fit the original analysis strategy.

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’s adverse-event figures report zero serious adverse events, zero other adverse events, and zero deaths in each listed catheter group. Each group reports 13 participants at risk for serious adverse events and 13 at risk for other adverse events. These are the counts recorded for the posted safety fields, not evidence that every possible adverse event was captured or that risk is absent.

Zero observed events in a small study can coexist with uncertainty about the frequency of uncommon events. In general, the ability to detect rare harms depends on the amount of exposure and the completeness and duration of follow-up. The registry gives the primary outcome timeframe as 12 months, but does not provide detailed safety follow-up methods or event definitions in the posted adverse-event fields.

The brief summary describes an aim involving no increase in adverse events, but the record’s zero counts cannot establish that the groups have equal safety. The adverse-event entries should be interpreted as what was reported in the registry, within the limits of the recorded counts and available follow-up details. They are not a basis for medical advice or a definitive comparison of risks.

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

The posted results describe plasma hemoglobin means of 16.8 for the standard-of-care catheter and 17.3 for the BD Nexiva Diffusics catheter. The reported mean difference is 0.5. The recalculated interval, from -8.038 to 9.038, is broad and includes zero, indicating substantial uncertainty about the size and direction of the contrast. This is a description of the posted outcome summaries, not a claim that the catheters are equivalent or that one has a clinically meaningful advantage.

The sponsor labels its ANOVA result as non-inferiority, but the registry record does not report the margin used for that conclusion. Non-inferiority is not established merely by a small estimated difference or a non-significant p-value. It requires a clinically justified margin, an appropriate design and analysis, and evidence that the uncertainty is consistent with the chosen criterion. Those elements cannot all be checked from the registry entry.

The record’s brief summary mentions pain and adverse events as part of the study hypothesis. The posted secondary outcome listed is return pressure >400 mmHg, and the primary outcome is plasma hemoglobin. A pain result is not reported among the posted outcomes described in the registry record. Consequently, the primary result cannot answer the entire hypothesis in the summary, and the available safety counts do not establish that adverse-event risks are equivalent.

The trial is described as a randomized pilot crossover study, but the registry does not explain the crossover sequence, how repeated measures were analyzed, or how the posted arm counts relate to encounters and participants. Those omissions, the small posted outcome counts, and the broad confidence interval all limit how far the results can be generalized or used to make a definitive comparison.

The appropriate reading is narrow: the registry reports similar-looking group means in this pilot record, alongside considerable uncertainty and incomplete methodological detail. It does not determine whether the intervention meets a non-inferiority standard, whether a difference is clinically important, or what the results would be in a larger study.

17. Why This Trial Matters Statistically

This trial is statistically interesting because its design is described as crossover while the posted primary results are presented as arm-level means and an ANOVA comparison. In a crossover study, the relationship between measurements from the same participant can be central to the analysis. Without details on sequences, periods, repeated observations, or the model, readers cannot tell whether the analysis uses that structure appropriately. This is an important interpretive issue, not a technical detail that can be resolved from the treatment labels alone.

The trial also illustrates the difference between estimating a contrast and establishing non-inferiority. The sponsor labels its analysis non-inferiority, but the registry does not report a margin. The recalculated estimate is 0.5, while its interval extends from -8.038 to 9.038. A point estimate near zero is not enough to show that effects outside a clinically acceptable range have been excluded. A prespecified margin and a suitable interval-based interpretation are necessary to make that statistical claim assessable.

The pilot context matters as well. The brief summary says the study was intended to refine and power a full randomized control trial. The planning illustrations based on the observed effect show how sensitive required sample sizes can be to the effect chosen for detection, but they are not the trial’s original design calculation. They should not be confused with observed power or treated as evidence about what the completed study could reliably detect.

Finally, endpoint descriptions and design fields are not fully aligned: the primary description refers to a mean plasma hemoglobin value while also describing dichotomous scoring, and the registry’s masking field differs from the brief summary. These points make careful reading of registry records essential. They identify questions a complete trial report would need to clarify before readers could fully assess the analysis and its implications.

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 important design details unresolved. It labels the trial randomized and crossover, but does not state the treatment sequence, whether every participant received both catheters, how many procedures each participant underwent, or how period and carryover effects were considered. The posted arm summaries do not explain whether their observation counts refer to people, encounters, or measurements. These gaps make it difficult to connect the summary comparison to the stated crossover design.

There is also a discrepancy in the description of masking: the design field says none, while the brief summary calls the study single blinded. The record does not identify who was blinded or reconcile the two descriptions. The primary endpoint text describes a continuous plasma hemoglobin mean but also says the test will be scored dichotomously as present or absent. The registry does not clarify how these outcome descriptions relate to each other.

The posted primary outcome summaries contain 13 observations per arm and the recalculated confidence interval is broad. The registry does not provide participant characteristics, eligibility criteria, a clinically important threshold, or a non-inferiority margin. It also does not give a detailed model specification, analysis population, missing-data method, or account of protocol deviations. The sponsor’s reported ANOVA result lacks a posted confidence interval.

The brief summary describes a planned target of 33 encounters in each group, with 66 encounters in total, while the primary outcome summaries report different observation counts. The record does not explain this distinction. Nor does it report the trial’s original sample-size justification, despite describing the pilot as preparation for a larger trial. These limitations prevent the posted summaries from answering all aspects of the stated hypothesis or supporting a fully reproducible statistical assessment.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit — NCT04253756.
• Registry record last updated 2022-06-06; status last verified 2022-05.
• Results first posted 2022-06-06.
• 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 describes a completed randomized crossover pilot study of plasma exchange in an outpatient apheresis unit. It compares an 18-gauge Autogard standard-of-care catheter with the 20-gauge BD Nexiva Diffusics catheter. The record gives an enrollment of 26 and lists a start date of 2020-03-31 and a primary completion date of 2021-04-15.

The primary outcome is mean plasma hemoglobin, with a stated timeframe of 12 months. The posted group means are 16.8 and 17.3, with a mean difference of 0.5. The recalculated unadjusted 95% confidence interval is -8.038 to 9.038, and the p-value is 0.909. The sponsor reports an ANOVA mean difference of 0.5 and p-value of 0.87, labeled non-inferiority, but the margin is not reported.

The registry reports zero serious adverse events, zero other adverse events, and zero deaths in both listed groups. Important details—including crossover procedures, the analysis population, missing-data handling, masking, and the original sample-size rationale—are not reported in the registry record.