This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment (NCT01474200), a randomized na study. The primary outcome is Time to First Heart Failure (HF) Event.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01474200 |
| Phase | NA |
| Condition | Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 224 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Nuwellis, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People hospitalized with acute decompensated heart failure were eligible for the study. The registry record describes the target as patients discharged after an index heart-failure hospitalization. It lists heart failure, cardiac failure, and acute decompensated heart failure as conditions. Further eligibility criteria and the characteristics of participants actually enrolled are not reported in the registry record.
Intervention
The intervention was isolated veno-venous ultrafiltration, described as aquapheresis using the Aquadex Flex Flow System. The intended fluid-removal approach was device-based ultrafiltration. The registry record does not give further details about treatment settings or how treatment was adjusted for individual participants.
Comparator
The comparator was intravenous loop diuretic treatment. Both approaches were intended to remove excess fluid. The trial was randomized, with parallel groups, and masking was listed as none. The specific allocation procedure and any steps taken to manage the effects of unmasked treatment are not reported in the registry record.
Primary question
The primary question was whether the time to a first heart-failure event within 90 days after discharge differed between the two treatment groups. An event could be a heart-failure rehospitalization, unscheduled outpatient or emergency-room treatment with intravenous loop diuretics, or unscheduled outpatient aquapheresis. The endpoint therefore includes more than hospital admissions: it also counts specified unscheduled outpatient or emergency care. The posted primary results are reported at the 25th percentile, rather than as medians, and the registry record does not report a sponsor hazard-ratio comparison.
3. Trial Design
AVOID-HF was a randomized, parallel-group study with no masking. It compared isolated veno-venous ultrafiltration, called aquapheresis in the record, with intravenous loop diuretics. The registry lists an enrollment of 224 and reports 110 participants in the aquapheresis arm and 111 in the intravenous loop diuretic arm for the primary endpoint. These are the posted endpoint group sizes; they should not be treated as an explanation of the difference between the enrollment figure and the endpoint counts.
The study addressed heart-failure events after discharge from an index heart-failure hospitalization. The primary follow-up window was 90 days after discharge. The registry lists study start as 2012-01 and primary completion as 2014-07. The status is terminated. The reason for termination, the timing of the decision, and whether termination affected follow-up or analysis are not reported in the registry record. The listed phase is NA.
Randomization is intended to support a fair comparison by assigning treatment independently of participants’ prognosis, on average. It does not guarantee that groups will be identical, and an unmasked design can leave treatment knowledge relevant to care, reporting, or endpoint assessment. The registry record does not describe the allocation sequence, concealment, endpoint adjudication, or other safeguards against bias.
The record identifies one primary endpoint and several secondary efficacy outcomes, including fluid removal, weight change, congestion, B-type natriuretic peptide, and length of stay. It lists 23 outcome measures, while the posted secondary results include 22. A protocol, analysis plan, and explanation for the difference are not reported in the registry record. The record also does not report a formal primary-endpoint analysis or the analysis population used for the posted results.
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
| Stage | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
|---|---|---|
| STARTED | 110 | 114 |
| COMPLETED | 81 | 84 |
| NOT COMPLETED | 29 | 30 |
Analysis population for the primary outcome, as defined in the registry: Results reported are for the 25th percentile.
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: 3 patients in the IV Loop Diuretics (LD) arm were randomized, but withdrawn from the study prior to beginning study treatment. These patients are excluded from the number of baseline participants (analysis population).
| Characteristic | Unit | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) | Total |
|---|---|---|---|---|
| Participants analysed | 110 | 111 | 221 | |
| Age, Continuous | Years | 67.03 (SD 12.61) | 66.87 (SD 13.45) | 66.95 (SD 13.01) |
| Sex: Female, Male: Female | Participants | 34 | 30 | 64 |
| Sex: Female, Male: Male | Participants | 76 | 81 | 157 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): Asian | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 31 | 30 | 61 |
| Race (NIH/OMB): White | Participants | 75 | 71 | 146 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 4 | 5 |
| Height | Centimeters | 172.45 (SD 11.04) | 174.12 (SD 10.52) | 173.29 (SD 10.79) |
| Weight | Kilograms | 110.06 (SD 32.26) | 110.92 (SD 35.09) | 110.49 (SD 33.64) |
| Body Mass Index (BMI) | Kg/m2 | 36.89 (SD 10.13) | 36.32 (SD 10.10) | 36.61 (SD 10.10) |
6. Primary Endpoint
The registry lists the primary outcome as Time to First Heart Failure (HF) Event, measured over 90 days after discharge from index HF hospitalization..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is time to first heart-failure event within 90 days after discharge from the index heart-failure hospitalization. It includes heart-failure rehospitalization, unscheduled outpatient or emergency-room treatment with intravenous loop diuretics, and unscheduled outpatient aquapheresis. Including specified outpatient and emergency treatments makes the endpoint broader than hospitalization alone. It aims to capture clinically important worsening that prompts additional treatment, even when it does not lead to admission.
Time-to-event endpoints retain information about when an event occurs, not only whether one occurred during follow-up. In general, they can account for participants whose event has not been observed by the end of their available follow-up, provided that the analysis appropriately handles censoring. The registry record does not report the censoring rules, follow-up completeness, or the statistical method used for the posted primary values.
The primary results are described as the 25th percentile. They are not medians. The aquapheresis group’s reported value is 62 days, with a 95% confidence interval from 42 days to an upper limit not reported in the registry record. The intravenous loop diuretic group’s value is 34 days, with a 95% confidence interval from 20 to 62 days. A percentile estimate describes a point in the event-time distribution; it is not itself a treatment-effect estimate. The registry record does not report a hazard ratio, a confidence interval for a between-group effect, or a sponsor-reported test for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results give the 25th percentile of time to first heart-failure event as 62 days for aquapheresis and 34 days for intravenous loop diuretics. The respective 95% confidence intervals are 42 days to an upper limit not reported in the registry record, and 20 to 62 days. These are group-specific percentile estimates, not an estimate of the difference between treatment groups. They do not by themselves establish whether the groups differ statistically or clinically.
A direct treatment comparison for a time-to-event outcome would commonly be expressed using a hazard ratio or another between-group measure, with an uncertainty interval and a stated analysis method. Those sponsor-reported results are not reported in the registry record. Nor is a primary-endpoint p-value reported. It is therefore not possible to use the posted percentile values alone to make a formal claim about the comparative effect of the treatments. The absence of a reported comparison is not evidence that the groups were equivalent.
The confidence interval gives information about precision for each percentile estimate. In general, a confidence interval represents uncertainty in an estimate under the assumptions of the analysis; it is not a range containing most individual participants’ event times. The upper confidence limit for the aquapheresis percentile is missing from the registry record, which prevents a complete reading of its reported interval. Even complete intervals for separate groups would not replace an interval for the treatment contrast.
The registry describes the outcome window as 90 days after discharge. The reported aquapheresis percentile is 62 days and the intravenous loop diuretic percentile is 34 days. These values concern the specified first-event endpoint, which includes certain unscheduled outpatient treatments as well as rehospitalization. They should not be interpreted as time to hospitalization alone, time to any worsening, or a measure of survival.
Interpretation also depends on how events were identified, how incomplete follow-up was handled, which participants were included, and whether the analysis followed randomized assignment. Those details are not reported in the registry record. The trial was unmasked, and the endpoint includes treatment decisions, so knowledge of assigned treatment could potentially be relevant to event ascertainment. The registry record does not explain whether endpoint assessment was independently adjudicated.
The study is listed as terminated, but the reason and its implications for the primary analysis are not reported. The posted result should therefore be read as a limited description of the reported percentile estimates, rather than as a complete comparative analysis of the primary question. The available information does not support a conclusion about the size, direction, or statistical significance of a treatment effect on time to first heart-failure event.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure. For each participant, the relevant time begins at discharge from the index heart-failure hospitalization and ends at the first qualifying heart-failure event, if one is observed during the stated follow-up window. The listed events include rehospitalization and specified unscheduled outpatient or emergency treatment. The record reports a percentile of the event-time distribution rather than a mean or a median. A percentile is a location within a distribution; it does not describe the experience of every participant.
Time-to-event analysis has to address incomplete observation. For example, some participants may have no recorded event before their available follow-up ends. In general, such observations may be censored: they contribute information up to the last time their event status is known, without being treated as if an event occurred then. Valid inference depends on appropriate methods and assumptions about censoring. The censoring approach, follow-up completeness, and specific estimator used for the registry’s percentile results are not reported in the registry record.
A confidence interval expresses uncertainty around an estimated quantity. Here, the registry labels the primary endpoint dispersion as a 95% confidence interval. The interval for the aquapheresis percentile has a reported lower limit of 42 days, but its upper limit is not reported in the registry record. The intravenous loop diuretic interval is reported as 20 to 62 days. These intervals concern the group-specific percentile estimates. They are not confidence intervals for a difference between groups.
A treatment comparison for time-to-event data might use a hazard ratio, which compares event rates over time under a particular model, or another suitable contrast. The registry record does not report the sponsor’s hazard ratio, its interval, or a primary-endpoint test. It lists no analyses in the posted record. General methodological possibilities should not be mistaken for the method actually used in this study: the specific model, covariates, handling of ties, and assumptions are not reported in the registry record.
The continuous secondary outcomes are reported as group means and standard deviations. The accompanying comparisons are unadjusted recalculations from the posted summary statistics, rather than sponsor-reported analyses. A mean difference describes the difference in group averages using the stated ordering; the confidence interval describes uncertainty in that recalculated contrast. The unadjusted p-value evaluates the contrast under its calculation assumptions, but does not account for multiple secondary outcomes. These recalculations do not substitute for the trial’s prespecified analysis, which is not reported in the registry record.
For general interpretation of a mean difference, its scale matters. Fluid outcomes are in mL and weight change is in lbs. A standard deviation describes variability among observations, not uncertainty in the mean itself. A confidence interval around a group difference instead reflects uncertainty in that estimated contrast. When observations are highly variable, the estimated difference may be imprecise, even if the group means appear separated. In general, distributions that are skewed or have outliers can also make means and standard deviations less representative of typical observations. The registry record does not provide distribution plots or describe distribution checks.
The sample-size figures associated with the continuous secondary comparisons are planning illustrations, not observed power and not the trial’s original design calculations. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect set to a stated fraction of the observed effect. The record explicitly distinguishes these calculations from the trial’s own design. Such illustrations show how a future study’s required participants per arm would change if it aimed to detect a smaller fraction of the observed effect. They are sensitive to the observed estimate and should not be read as proof that the current study was adequately or inadequately powered. The protocol’s sample-size justification is not reported in the registry record.
Over-dispersion is a general concern when data vary more than a model assumes. If a model underestimates variability, its standard errors can be too small and confidence intervals too narrow. That concern is most directly relevant to analyses using a distributional model for counts or rates; it should not be asserted as a problem in this study without evidence. The registry record does not describe count-model analyses for the primary endpoint. More generally, endpoint-specific modeling choices and sensitivity analyses are not reported.
Randomization supports comparison by reducing systematic differences in prognosis on average, but analysis choices still matter. An intention-to-treat analysis would generally retain participants in their randomized groups, while other analysis populations can exclude or reclassify some participants. The registry record does not state which analysis population was used. It also does not report the handling of missing outcome values, protocol deviations, or treatment discontinuation. These omissions limit assessment of how closely posted estimates reflect the randomized comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary endpoint and many outcome measures, but does not report a statistical analysis plan or a multiplicity strategy. When several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. In general, prespecifying a primary hypothesis and controlling multiplicity where appropriate helps distinguish confirmatory evidence from exploratory findings. The record does not explain whether secondary outcomes were treated as exploratory, whether any ordering was prespecified, or whether an adjustment was made.
The posted secondary comparisons have unadjusted p-values and are recalculations from summary statistics. They should not be interpreted as multiplicity-adjusted evidence. The registry record does not report sponsor analyses for these outcomes. The reported primary percentile estimates also lack a sponsor-reported between-group test or hazard ratio, so a multiplicity discussion cannot substitute for the missing primary comparison.
Missing-data methods and analysis populations are not reported in the registry record. It does not say whether all randomized participants were analyzed as assigned, whether a modified population was used, or how participants with missing endpoint information were handled. For the primary time-to-event endpoint, censoring rules and follow-up completeness are also not reported. These details matter because estimates can depend on which observations contribute and how incomplete follow-up is represented.
The posted group sizes vary among outcomes. That variation indicates that the number of observations used is not identical for every reported endpoint, but the record does not explain why. It does not identify whether differences arose from missing measurements, eligibility for a particular assessment, or another reason. No assumptions about the cause or likely direction of any bias can be justified from the registry record.
There is also no reported account of interim analyses, stopping rules, protocol deviations, or sensitivity analyses. Those elements may affect how results are interpreted, but their presence or absence cannot be inferred. The study is listed as terminated; the record does not report the reason, whether stopping was related to the accumulating results, or what consequences termination had for data collection and analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | 73 | 110 | 66.4% |
| IV Loop Diuretics (LD) | 67 | 111 | 60.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | 25 of 110 |
| IV Loop Diuretics (LD) | 18 of 111 |
Most frequent serious adverse event terms
| Event term | Organ system | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
|---|---|---|---|
| Cardiac Failure Acute | Cardiac disorders | 13 of 110 | 19 of 111 |
| Cardiac Failure Congestive | Cardiac disorders | 11 of 110 | 20 of 111 |
| Cardiac Failure | Cardiac disorders | 5 of 110 | 8 of 111 |
| Hypotension | Vascular disorders | 3 of 110 | 5 of 111 |
| Renal Failure Acute | Renal and urinary disorders | 4 of 110 | 3 of 111 |
| Chest Pain | General disorders | 4 of 110 | 1 of 111 |
| Pneumonia | Infections and infestations | 5 of 110 | 0 of 111 |
| Atrial Fibrillation | Cardiac disorders | 3 of 110 | 2 of 111 |
| Cardiac Arrest | Cardiac disorders | 3 of 110 | 2 of 111 |
| Cardiac Failure Chronic | Cardiac disorders | 2 of 110 | 3 of 111 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
|---|---|---|---|
| Hypotension | Vascular disorders | 12 of 110 | 7 of 111 |
| Hyperkalaemia | Metabolism and nutrition disorders | 8 of 110 | 4 of 111 |
| Renal Failure Acute | Renal and urinary disorders | 5 of 110 | 7 of 111 |
| Blood Creatinine Increase | Investigations | 7 of 110 | 4 of 111 |
| Urinary Tract Infection | Infections and infestations | 3 of 110 | 7 of 111 |
Serious events with the highest arm-level rate: cardiac failure congestive (18.0%), cardiac failure acute (17.1%), cardiac failure (7.2%), pneumonia (4.5%), hypotension (4.5%).
The registry lists serious adverse events for 73 of 110 participants in the aquapheresis group and 67 of 111 in the intravenous loop diuretic group. It separately lists other adverse events for 25 of 110 and 18 of 111, respectively. These are descriptive group counts in the registry record. They do not, on their own, establish whether an observed difference is attributable to treatment. The record does not report a comparative safety analysis, confidence intervals, or a statistical test for these figures.
The listed serious-event terms include Cardiac Failure Congestive at 18.0%, Cardiac Failure Acute at 17.1%, Cardiac Failure at 7.2%, Pneumonia at 4.5%, Hypotension at 4.5%, and Chest Pain at 3.6%. The registry record does not clarify the denominator, whether terms can overlap within a participant, or how the displayed term percentages relate to treatment groups. They should not be summed or treated as mutually exclusive categories.
Death counts are not reported in the registry record. The record also does not provide enough detail to assess event timing, severity grading beyond the serious-event classification, relatedness to treatment, or how adverse events were collected. These figures are not a complete comparative safety assessment and should be read alongside those limitations.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of aquapheresis and intravenous loop diuretics and reports group-specific estimates for the 25th percentile of time to first heart-failure event. Those estimates are 62 days for aquapheresis and 34 days for intravenous loop diuretics. The record does not provide a sponsor-reported hazard ratio, confidence interval for a treatment contrast, or primary-endpoint test. The posted values therefore do not establish the size, precision, or statistical significance of a comparative effect.
Nor do these results show that the treatments are equivalent. Demonstrating equivalence or non-inferiority requires an appropriate design, a prespecified margin, and a suitable analysis. Such information is not reported in the registry record. The absence of a reported significant comparison would not, by itself, show equivalence; in this record, even a sponsor-reported primary test is not available.
The endpoint is specifically time to the first listed heart-failure event within 90 days after discharge. It includes specified unscheduled outpatient and emergency treatments as well as rehospitalization. It does not represent every possible heart-failure outcome, long-term outcomes, or time to death. Death counts for the safety listing are not reported, and the primary endpoint’s handling of death is not described.
Secondary measures concern fluid removal, weight, congestion, biomarkers, and length of stay during or around the index hospitalization. They can offer context about different aspects of treatment, but they are not substitutes for the primary endpoint analysis. The secondary comparisons are unadjusted recalculations, and the registry record does not describe multiplicity control or a prespecified secondary-outcome interpretation plan.
The trial’s randomized design is relevant to causal interpretation, but the unmasked conduct, missing analysis details, unavailable upper confidence limit for one primary estimate, and lack of a reported between-group primary analysis constrain what can be concluded. The termination status adds a question about study conduct, but its reason and consequences are not reported. The record supports a description of the posted results and their uncertainty, not a treatment recommendation or a definitive claim about comparative benefit or harm.
13. Why This Trial Matters Statistically
This trial raises several important statistical issues in a setting where outcomes occur after hospital discharge. The primary measure is time to an event, so the timing and completeness of follow-up matter in addition to whether an event was recorded. Interpretation requires knowing how participants without an observed event were handled, how event times were assessed, and how the groups were compared. Those details are not reported in the registry record.
It also illustrates the distinction between an estimate within each treatment group and an estimate of treatment effect. The posted 25th-percentile values describe each group separately. A between-group hazard ratio or other contrast would address the comparative question more directly. Without that result, reading a difference between the point estimates as proof of a treatment effect would overstate what the record establishes.
The endpoint definition is another substantive issue. Counting specified unscheduled outpatient treatment alongside rehospitalization broadens the outcome beyond admission. In an unmasked trial, care decisions and event ascertainment may be influenced by treatment knowledge; whether that occurred cannot be determined from the record. The lack of reported adjudication procedures leaves an important aspect of measurement quality unclear.
The many secondary measures make multiplicity relevant. Fluid and weight outcomes may help describe treatment effects during hospitalization, but numerous outcomes and unadjusted comparisons make isolated results less conclusive. The trial also has varying group sizes across outcomes, without a registry explanation of the differences. Together, these features show why a clear protocol, analysis plan, missing-data description, and complete primary comparison are essential for interpreting randomized clinical-trial results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations constrain interpretation. The study was unmasked, and its primary endpoint includes unscheduled outpatient or emergency treatment decisions as well as rehospitalization. The registry record does not report whether events were adjudicated independently or whether any safeguards addressed the possibility that knowledge of treatment could affect event identification.
The primary result is incomplete as a comparative analysis. It reports group-specific 25th-percentile estimates, but no sponsor-reported hazard ratio, treatment contrast, or primary test. The upper confidence limit for the aquapheresis estimate is not reported in the registry record. The reason that this limit is missing is not stated.
The study is listed as terminated, but the record does not report why it ended, whether termination was planned, or how it affected follow-up, enrollment, or analyses. The registry lists enrollment as 224, while the posted primary endpoint group sizes are 110 and 111. The record does not explain the relationship between these figures, and no reconciliation should be assumed.
Eligibility criteria, baseline participant characteristics, allocation-concealment details, analysis populations, missing-data methods, censoring rules, and endpoint-assessment procedures are not reported in the registry record. Outcome-specific group sizes vary, with no explanation of the variation. The record also does not report the trial’s sample-size justification, interim analyses, or a complete statistical analysis plan.
Finally, the posted secondary comparisons are unadjusted recalculations, not sponsor-reported analyses, and no multiplicity strategy is reported. The safety information is limited to counts and listed serious-event terms; death counts and a comparative safety analysis are not reported. These limitations do not determine the direction of any bias, but they restrict how confidently the posted results can answer the clinical question.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment — NCT01474200.
- Registry record last updated 2023-08-29; status last verified 2023-08.
- Results first posted 2015-10-12.
- 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.
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18. Record Summary
NCT01474200, titled AVOID-HF, was a randomized, parallel-group, unmasked study comparing aquapheresis by isolated veno-venous ultrafiltration with intravenous loop diuretics. The registry lists enrollment of 224, study start as 2012-01, primary completion as 2014-07, and status as terminated. The reason for termination is not reported in the registry record.
The primary endpoint was time to first heart-failure event within 90 days after discharge from an index heart-failure hospitalization. Results are reported at the 25th percentile: 62 days for aquapheresis, with a 95% confidence interval lower limit of 42 days and an upper limit not reported; and 34 days for intravenous loop diuretics, with a 95% confidence interval from 20 to 62 days. A sponsor-reported comparative primary analysis is not reported in the registry record.
The record also includes secondary efficacy outcomes and adverse-event counts. Analysis populations, missing-data methods, multiplicity procedures, and the reason for termination are not reported in the registry record.