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 Gel-One Treatment in Knee Osteoarthritis (NCT01934218), a randomized na study. The primary outcome is Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01934218 |
| Phase | NA |
| Condition | Osteoarthritis Knee |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 814 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Seikagaku Corporation |
| Results posted | Yes |
2. Clinical Question
Population
People with osteoarthritis of the knee were enrolled. The registry lists enrollment as 814, but does not report a more detailed description of the primary analysis population. Eligibility criteria and the characteristics of participants at baseline are not reported in the registry record.
Intervention
The intervention was a single intra-articular injection of 3 mL of Gel-One. The trial title describes an open-label safety extension, but details about its duration and the participants included are not reported in the registry record.
Comparator
The comparator was a single intra-articular injection of 3 mL of phosphate buffered saline (PBS). The registry describes the study as PBS-controlled and randomized, with double masking.
Primary question
The primary question was whether Gel-One was superior to PBS for knee pain measured during a 50-foot walk. The outcome was change from baseline in a visual analogue score (VAS), assessed through Week 26. The registry reports a mean difference of 0.0, with a 95% confidence interval from -2.7 to 2.7 and p = 0.988.
3. Trial Design
The registry describes a multicenter, randomized, double-blind, parallel-group study comparing a single intra-articular injection of Gel-One with a single injection of phosphate buffered saline. Both injections were 3 mL. The trial title also describes an open-label safety extension; further details about that extension are not reported in the registry record.
The study is listed as completed. Its start is recorded as 2013-08 and its primary completion as 2016-03. The listed enrollment is 814. The registry classifies the phase as NA. The sponsor is Seikagaku Corporation.
Randomization is intended to reduce systematic differences between treatment groups at allocation. Double masking can reduce the influence of knowledge about treatment assignment on participants’ reports and on study conduct. These are general design principles; the registry record does not describe how randomization or masking was implemented, or which people were masked.
The outcome results list 402 participants in the Gel-One arm and 407 in the placebo arm. The record does not explain how these arm counts relate to the enrollment figure, or identify the analysis population from which they were drawn. The serious and other adverse-event summaries use separate at-risk counts, so those counts should be read as belonging to the safety summaries rather than assumed to represent the primary outcome population.
The record gives two outcome measures and two analyses, but identifies no posted secondary outcome results. It does not report a detailed statistical analysis plan, the timing of any interim analyses, or a sample-size justification. Those details are not reported in 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.
Double-blind Phase
| Stage | Gel-One | Placebo |
|---|---|---|
| STARTED | 404 | 410 |
| Analyzed Participants | 402 | 407 |
| COMPLETED | 356 | 356 |
| NOT COMPLETED | 48 | 54 |
Reasons for not completing this period:
| Reason | Gel-One | Placebo |
|---|---|---|
| Adverse Event | 8 | 8 |
| Lack of Efficacy | 6 | 7 |
| Lost to Follow-up | 7 | 14 |
| Physician Decision | 1 | 2 |
| Protocol Violation | 4 | 0 |
| Withdrawal by Subject | 16 | 13 |
| Noncompliance with Study Protocol | 5 | 8 |
| Protocol Violation of Study Eligibility | 1 | 2 |
Open-Label Phase
| Stage | Gel-One | Placebo |
|---|---|---|
| STARTED | 316 | 328 |
| COMPLETED | 290 | 304 |
| NOT COMPLETED | 26 | 24 |
Reasons for not completing this period:
| Reason | Gel-One | Placebo |
|---|---|---|
| Adverse Event | 2 | 4 |
| Lack of Efficacy | 1 | 4 |
| Lost to Follow-up | 4 | 2 |
| Physician Decision | 1 | 0 |
| Protocol Violation | 1 | 0 |
| Withdrawal by Subject | 13 | 11 |
| Noncompliance with Study Protocol | 4 | 2 |
| Failure to Exam Primary Evaluation | 0 | 1 |
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.
| Characteristic | Unit | Gel-One | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 402 | 407 | 809 | |
| Age, Continuous | years | 59.3 (SD 9.14) | 59.8 (SD 9.32) | 59.6 (SD 9.23) |
| Sex: Female, Male: Female | Participants | 221 | 234 | 455 |
| Sex: Female, Male: Male | Participants | 181 | 173 | 354 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 35 | 28 | 63 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 367 | 379 | 746 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 52 | 52 | 104 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 93 | 70 | 163 |
| Race (NIH/OMB): White | Participants | 247 | 277 | 524 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 10 | 7 | 17 |
| Body mass index | kilograms / meter square | 28.597 (SD 4.1923) | 28.797 (SD 3.9244) | 28.698 (SD 4.0585) |
| Kellgren-Lawrence score: 1 | participants | 113 | 111 | 224 |
| Kellgren-Lawrence score: 2 | participants | 161 | 164 | 325 |
| Kellgren-Lawrence score: 3 | participants | 128 | 132 | 260 |
| osteoarthritis knee disease duration | years | 6.80 (SD 7.835) | 6.90 (SD 7.072) | 6.85 (SD 7.456) |
| Etiology: Idiopathic | participants | 359 | 359 | 718 |
| Etiology: Post-traumatic | participants | 43 | 48 | 91 |
| Study knee: Right | participants | 209 | 212 | 421 |
| Study knee: Left | participants | 193 | 195 | 388 |
| 50-foot walk test VAS pain score | mm | 69.25 (SD 7.640) | 69.36 (SD 7.817) | 69.31 (SD 7.725) |
| 50-foot walk test contralateral VAS pain score | mm | 11.50 (SD 7.536) | 11.95 (SD 7.565) | 11.73 (SD 7.549) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26, measured over Baseline up to Week26.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mm |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the visual analogue score (VAS) recorded after a 50-foot walk, followed through Week 26. The registry describes the score on a 100 mm scale: 0 mm means no pain and 100 mm means extreme pain. The reported group values are mean changes, so a negative value indicates that the score at follow-up was lower than the baseline score.
A walk-related pain measure captures pain in the context of a specified activity rather than asking only about pain at rest. In general, a VAS gives participants a continuous scale on which to record the intensity of a subjective experience. A continuous measure can retain more gradation than a response with only a few categories, although its interpretation depends on how it is administered and how scores are analyzed.
The registry says change through Week 26 was estimated using a longitudinal model. Such models can use measurements collected at multiple visits to characterize change over time. The record does not report the visit schedule, the model specification, the assumptions used for missing measurements, or the population included in the primary analysis. The title of the endpoint says “through Week 26,” while the precise data handling at each visit is not described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The arm summaries report a mean change of -31.7 for Gel-One and -31.7 for placebo. Each has a reported 95% confidence interval from -33.7 to -29.6. These are within-arm estimates of change from baseline. They do not, by themselves, answer whether the groups differ: a comparison between groups is needed for that question.
The registry’s reported superiority analysis gives a mean difference in final values of 0.0, with a 95% confidence interval from -2.7 to 2.7 and p = 0.988. This is the posted between-group result. The interval includes zero and extends in both directions, so the reported estimate is compatible with a range of small differences favoring either group under the analysis. The p-value indicates that the reported data do not provide evidence against the null value of no difference under the stated test. It is not the probability that the null hypothesis is true, nor does it establish that the groups are equivalent.
The endpoint is described as change from baseline, while the reported analysis parameter is “Mean Difference (Final Values).” The registry also describes a longitudinal model for estimating change through Week 26. Because the record does not give the full analysis specification, it is not possible to determine precisely how the final-values comparison relates to the repeated-measure model or to reconstruct the analysis.
The equal arm changes and the reported mean difference of 0.0 are consistent with little separation in the posted point estimates. They do not demonstrate that all participants experienced the same change, and the arm-level confidence intervals do not quantify the uncertainty in an individual participant’s response. The between-group confidence interval is the relevant reported precision measure for the comparison.
Interpretation also depends on the analysis population, missing outcome data, model assumptions, and how the longitudinal measurements were handled. Those details are not reported in the registry record. Accordingly, the result should be read as the registry’s reported estimate for its stated analysis, not as a complete account of every possible analysis or of the trial’s full clinical context.
9. Statistical Methods Explained
The primary outcome is continuous: it is a mean change in a VAS score. A continuous outcome can take many values along a scale, and its group summary is commonly expressed as a mean. The registry reports the mean change and a confidence interval for each arm, as well as a separate between-group analysis. The interpretation of these quantities depends on what population and time point the model targets.
What does a confidence interval express?
In general, a confidence interval describes the precision of an estimate under the statistical method used to calculate it. A narrower interval indicates greater precision than a wider interval, all else equal. It does not mean that a specified proportion of individual participant scores lie inside the interval. Nor does a confidence interval correct bias caused by a misspecified model, selective reporting, or missing data handled under inappropriate assumptions.
For the arm summaries, the registry reports a 95% confidence interval from -33.7 to -29.6 for each group’s mean change. For the between-group result, it reports a 95% confidence interval from -2.7 to 2.7 around the mean difference of 0.0. These intervals address different estimates: one describes each arm’s mean change, and the other describes the reported comparison. A confidence interval for a group’s change cannot substitute for an interval for the difference between groups.
How should the p-value be read?
In general, a p-value measures how unusual the observed data, or more extreme data, would be under a specified null hypothesis and statistical model. It is not a measure of the size or clinical importance of an effect. The reported p = 0.988 belongs to the registry’s superiority analysis. It should be interpreted together with the estimated difference and its confidence interval, not as a standalone judgment about equivalence or practical importance. The registry does not report an equivalence or non-inferiority analysis.
What does the longitudinal model contribute?
Repeated measurements can describe how an outcome changes across follow-up rather than relying on a single measurement alone. In general, a longitudinal model accounts for the relationship among measurements from the same participant and estimates a pattern or summary across time. The registry says that change through Week 26 was estimated using a longitudinal model, but it does not report the model’s mathematical form, covariance structure, covariates, visit schedule, or handling of measurements after participants miss a visit.
Model-based analysis can make use of available observations, but its conclusions depend on its assumptions. Missingness may be related to observed or unobserved outcomes, and different assumptions can lead to different estimates. The record does not state the assumptions used for missing data or report sensitivity analyses, so the robustness of the result to alternative missing-data assumptions cannot be assessed from the registry record.
Why compare the randomized groups?
In general, a randomized comparison is designed to estimate the difference between assigned groups while reducing confounding at allocation. The PBS group provides a control for the injection procedure and the study context. Randomization does not guarantee that every aspect of conduct or follow-up is free from bias, and the registry record does not report enough implementation detail to assess those features. Double masking may help limit some influences of treatment knowledge, but the record does not identify who was masked or how masking was maintained.
Why is no recalculated comparison available?
The posted arm summaries give mean changes and confidence intervals, but the registry analysis reports a comparison using final values and a basic longitudinal model. The record does not provide the information needed to reconstruct that model-based comparison from the arm summaries alone. The recalculation output is marked as missing or not estimable for a two-arm continuous endpoint. A simple calculation based on summary statistics would not necessarily reproduce an adjusted or longitudinal model estimate, even if the necessary summaries were available.
Planning illustrations based on an observed effect are not observed power. In general, such illustrations show what sample size might be needed under specified planning assumptions; they do not describe the probability that the completed trial detected an effect. The record’s stated planning assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation. The registry record does not report the trial’s own sample-size justification or a planning result that can be interpreted as the trial’s observed power.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Basic longitudinal model | Mean Difference (Final Values) 0.0 | -2.7 to 2.7 | 0.988 |
The registry’s reported analysis is the sponsor-reported result available for the primary comparison: a mean difference in final values of 0.0, with a 95% confidence interval from -2.7 to 2.7 and p = 0.988. The posted arm summaries show mean changes of -31.7 in both groups, with a 95% confidence interval from -33.7 to -29.6 for each.
No independent recalculated comparison is available. The recalculation was not estimable for a two-arm continuous endpoint from the information recorded. In particular, the registry describes a basic longitudinal model, while the arm summaries alone do not provide its full specification or the data needed to reproduce its estimate. A recalculation from summary statistics would be a simple unadjusted calculation, not a replacement for the sponsor’s model-based analysis.
The discrepancy flag is false, so the record does not identify a conflict between a recalculated result and the sponsor’s result. In cases where a discrepancy is flagged, the sponsor’s own analysis takes precedence. Here, the useful distinction is that the sponsor analysis is reported, while a separate recalculated comparison is unavailable; the latter should not be treated as confirmation or contradiction of the reported result.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and two analyses, but the registry entries identify one primary endpoint and no posted secondary outcome results. The record does not report whether additional outcomes, time points, subgroup analyses, or interim analyses were considered. It also does not describe any adjustment for testing multiple hypotheses. Without that information, the possible impact of multiplicity on interpretation cannot be assessed from the registry record.
In general, testing multiple outcomes or multiple versions of an analysis can increase the chance of obtaining a nominally unusual result by chance. Prespecifying a primary outcome and analysis can help clarify which result is central, but the record does not include a detailed statistical analysis plan or establish when analysis choices were finalized. This absence does not show that multiplicity occurred; it means the relevant procedures are not reported in the registry record.
The primary endpoint description says that change through Week 26 was estimated using a longitudinal model. The record does not report the analysis population, the number of participants contributing outcome data at each visit, or the amount and pattern of missing outcome data. It also does not explain whether the analysis followed randomized assignment, whether participants were excluded, or how deviations from assigned treatment were handled. These details are important for understanding exactly which effect the estimate represents.
In general, missing-data methods rely on assumptions about why measurements are unavailable. A model that uses observed measurements does not automatically remove the possibility of bias if missingness is related to unobserved outcomes. The record does not report sensitivity analyses that explore alternative assumptions. As a result, the extent to which the primary estimate would change under different missing-data approaches is not reported in the registry record.
The safety summaries use at-risk counts, but their relationship to the outcome analysis population is not described. The record also does not state whether any interim looks at efficacy data took place. These omissions limit assessment of the analysis process; they do not establish that a particular unreported procedure was or was not used.
12. 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 |
|---|---|---|---|
| Gel-One | 7 | 404 | 1.7% |
| Placebo | 6 | 410 | 1.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Gel-One | 0 of 404 |
| Placebo | 0 of 410 |
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 |
|---|---|
| Gel-One | 107 of 404 |
| Placebo | 113 of 410 |
Most frequent serious adverse event terms
| Event term | Organ system | Gel-One | Placebo |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 404 | 1 of 410 |
| Joint effusion | Musculoskeletal and connective tissue disorders | 1 of 404 | 0 of 410 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 404 | 0 of 410 |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 404 | 0 of 410 |
| Coronary artery disease | Cardiac disorders | 1 of 404 | 0 of 410 |
| Acute myocardial infarction | Cardiac disorders | 0 of 404 | 1 of 410 |
| Aortic valve incompetence | Cardiac disorders | 0 of 404 | 1 of 410 |
| Osteomyelitis | Infections and infestations | 1 of 404 | 0 of 410 |
| Deep vein thrombosis | Vascular disorders | 1 of 404 | 0 of 410 |
| Chest pain | General disorders | 0 of 404 | 1 of 410 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Gel-One | Placebo |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 44 of 404 | 42 of 410 |
| Joint swelling | Musculoskeletal and connective tissue disorders | 33 of 404 | 42 of 410 |
| Joint effusion | Musculoskeletal and connective tissue disorders | 30 of 404 | 29 of 410 |
Serious events with the highest arm-level rate: arthralgia (0.2%), joint effusion (0.2%), basal cell carcinoma (0.2%), oesophageal adenocarcinoma (0.2%), coronary artery disease (0.2%).
The safety summaries report serious adverse events among 7 of 404 participants at risk in the Gel-One group and 6 of 410 at risk in the placebo group. The record reports no deaths in either group. It also lists other adverse events affecting 107 of 404 participants at risk in the Gel-One group and 113 of 410 at risk in the placebo group.
These counts describe events recorded in the registry and should not be read as a complete account of severity, timing, duration, or causal relationship to treatment. The record does not provide definitions for the safety categories or explain how events were assessed. It also does not state whether participants could experience more than one event, so event counts and participant counts should not be treated as interchangeable.
The serious-event terms listed include arthralgia, joint effusion, basal cell carcinoma, oesophageal adenocarcinoma, coronary artery disease, and osteomyelitis; each is reported as 0.2%. The registry does not provide further detail about event timing, individual circumstances, or attribution. These summaries are descriptive and do not establish that treatment caused or prevented an event. Differences in recorded counts alone do not establish a safety difference between the groups.
13. What the Result Does, and Does Not, Mean
The posted primary analysis estimates a mean difference in final values of 0.0, with a 95% confidence interval from -2.7 to 2.7 and p = 0.988. The arm summaries report the same mean change, -31.7, for both groups. These results show little separation in the reported point estimates for the endpoint and analysis as recorded. The confidence interval conveys uncertainty around the comparison, and it includes values on either side of zero.
This result does not demonstrate that the treatments are equivalent. Equivalence is a distinct statistical question that requires a prespecified margin defining how much difference would be considered acceptably small and an analysis designed to test that question. No equivalence margin or equivalence analysis is reported in the registry record. A non-significant superiority test is not, by itself, evidence of equivalence.
The finding also does not show that no participant experienced pain or that individual responses were uniform. The reported arm estimates are averages, and the registry does not provide the distribution of individual changes. Nor does the result, on its own, establish the clinical importance of a difference: the record does not report a threshold for a meaningful change in VAS score.
Interpretation is limited by the absence of a detailed analysis population, model specification, missing-data information, and sensitivity analyses. The primary outcome is described as change through Week 26, while the reported comparison is described as a difference in final values. The registry does not provide enough detail to reconcile these descriptions fully.
The findings concern the recorded VAS endpoint and reported analysis in this trial. They should not be extended to outcomes, time points, populations, or treatment settings that are not described in the registry record. The safety summaries likewise provide descriptive event counts, not proof of cause or a complete characterization of risk.
14. Why This Trial Matters Statistically
This trial offers a useful example of why within-group change and between-group comparison answer different questions. Both arms have a reported mean change of -31.7, but the primary question concerns the difference between assigned groups. The registry separately reports that comparison as a mean difference in final values of 0.0, with a 95% confidence interval from -2.7 to 2.7. A reader should therefore distinguish improvement relative to baseline within each arm from evidence about comparative performance.
It also illustrates the importance of matching the analysis description to the endpoint. The endpoint is framed as change from baseline through Week 26 and is described as estimated with a longitudinal model, while the reported analysis parameter is mean difference in final values. These labels may reflect aspects of the registry’s analysis, but the record does not provide enough detail to establish their exact relationship. Clear reporting of estimands, model specifications, visit handling, and analysis populations helps readers interpret such results.
A further statistical lesson is that a high p-value does not establish equivalence. The estimate and confidence interval describe the observed comparative result and its precision under the analysis; a formal equivalence conclusion would require a prespecified margin and an appropriate analysis. Neither is reported.
Finally, the unavailable recalculation is a reminder that group summaries cannot necessarily reproduce a longitudinal model analysis. Model-based estimates may depend on repeated measurements and assumptions that are not contained in arm means and confidence intervals. The sponsor-reported analysis remains the available comparison, while the registry’s omissions limit independent reconstruction and assessment of robustness.
15. 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 does not report detailed eligibility criteria, baseline characteristics, or a defined primary analysis population. Although it lists enrollment as 814 and gives arm counts for the primary outcome and separate at-risk counts for safety, it does not explain how these populations relate. Those figures should not be combined or interpreted as if their relationship were documented.
The primary endpoint is described as change through Week 26, estimated with a longitudinal model, while the analysis parameter is described as a mean difference in final values. The model specification, visit schedule, covariates, and handling of within-participant correlation are not reported. These omissions prevent a full reconstruction of the comparison and make it difficult to assess whether the reported parameter exactly corresponds to the endpoint description.
Information on missing outcome data, participant exclusions, adherence to assigned treatment, and sensitivity analyses is not reported in the registry record. The record also does not give a sample-size justification, a detailed statistical analysis plan, or information about interim analyses or adjustment for multiple testing. Without these details, readers cannot fully evaluate the prespecification and robustness of the analysis.
The registry title mentions an open-label safety extension, but the extension’s duration, enrollment, follow-up procedures, and results are not reported in the listed details. The safety summaries also lack event definitions, timing, attribution, and details about recurrent events. The reported serious-event terms therefore provide only a limited descriptive view of safety.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Gel-One Treatment in Knee Osteoarthritis — NCT01934218.
- Registry record last updated 2023-03-23; status last verified 2023-03.
- Results first posted 2017-07-02.
- 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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19. Record Summary
NCT01934218 is a completed, randomized, double-blind, parallel-group study of a single 3 mL intra-articular Gel-One injection versus a single 3 mL PBS injection for knee osteoarthritis. The registry lists enrollment as 814 and describes an open-label safety extension in the trial title.
The primary endpoint was change from baseline in VAS score after a 50-foot walk through Week 26. Both arms had a reported mean change of -31.7. The reported mean difference in final values was 0.0, with a 95% confidence interval from -2.7 to 2.7 and p = 0.988. No recalculated comparison is available from the recorded summaries.
The record reports serious adverse events in both groups and no deaths. Important details about the primary analysis population, longitudinal model, missing data, and safety-event assessment are not reported in the registry record.