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 A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (NCT00501059), a randomized phase 3 study. The primary outcome is Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00501059 |
| Phase | Phase 3 |
| Condition | Moderate Risk of CVD |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 12546 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
Adults described in the record as being at moderate risk of cardiovascular disease, without a history of known cardiovascular disease. The study summary characterizes the target group as having moderate risk of major coronary heart disease events and describes an approximate 10-year coronary heart disease risk of 10-20%, corresponding to a mean 10-year cardiovascular disease risk of approximately 30%.
Intervention
Enteric-coated acetylsalicylic acid, also called aspirin, taken as one 100 mg tablet orally once daily.
Comparator
A matching placebo taken as one tablet orally once daily. Participants were treated in a standard-care setting and could also receive treatment for underlying risk factors as determined by their treating physician.
Primary question
How did the time to the first confirmed occurrence of myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack compare between the randomized groups? The registry record describes this question but does not report a comparative primary-outcome estimate.
The trial addresses a primary-prevention question: whether assignment to daily acetylsalicylic acid rather than placebo changes the time until a first event in a composite of cardiovascular outcomes among people described as being at moderate risk and with no known history of cardiovascular disease. The composite combines events that may differ in clinical severity and frequency. Its purpose is to capture a broader set of first cardiovascular events than any single component alone.
The question is about assignment to the study groups under the trial conditions, not about the effect of aspirin in every population or setting. The record states that underlying risk factors could be treated according to the treating physician’s judgment, so the comparison was embedded in standard care rather than a setting in which other risk-factor treatment was withheld. The intended population, treatment, comparator, and endpoint are described, but the record does not report the primary-outcome event counts, estimated between-group effect, confidence interval, or p-value. The magnitude and precision of any difference therefore cannot be assessed from the reported information.
3. Trial Design
This was a Phase 3, randomized, parallel-group study with placebo control. The registry record lists triple masking, while the official title describes the study as double-blind. The record does not explain the difference between those descriptions or specify which groups of people were masked. Masking can, in general, reduce the risk that knowledge of assigned treatment influences care, outcome assessment, or reporting; the record says that outcome events were to be adjudicated by an Endpoint Adjudication Committee.
The trial enrolled 12546 participants, with 6276 assigned to placebo and 6270 assigned to acetylsalicylic acid in the posted adverse-event group counts. The primary analysis population is described as intention-to-treat and includes all participants randomized to their assigned study drug. The treatment group received one 100 mg enteric-coated tablet orally once daily; the comparator group received one matching placebo tablet orally once daily.
The study summary describes participants as having moderate cardiovascular risk and no history of known cardiovascular disease. It also says that participants were treated in a standard-care setting and could receive treatment for underlying risk factors according to their treating physician. The study start date is 2007-07-05, primary completion is listed as 2016-11-15, and the status is completed. The intended follow-up is described as approximately 6 years, until follow-up. The record does not report the actual follow-up duration for each participant or the number who completed follow-up.
The study was sponsored by Bayer. An independent Data Safety Monitoring Board is mentioned in the study summary. The record does not describe the board’s review schedule, recommendations, or any interim analyses. It also does not report a protocol-level sample-size justification or the planned statistical analysis in enough detail to reconstruct those decisions.
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 | Acetylsalicylic Acid (Aspirin, BAYE4465) | Placebo |
|---|---|---|
| STARTED | 6270 | 6276 |
| COMPLETED | 4402 | 4384 |
| NOT COMPLETED | 1868 | 1892 |
Reasons for not completing this period:
| Reason | Acetylsalicylic Acid (Aspirin, BAYE4465) | Placebo |
|---|---|---|
| Protocol Violation | 80 | 69 |
| Death | 140 | 137 |
| Other | 236 | 239 |
| Missing end-of-study page | 91 | 92 |
| Clinical endpoint reached | 110 | 123 |
| Insufficient therapeutic effect | 4 | 5 |
| Consent withdrawn by subject | 817 | 873 |
| Non-compliant with study treatment | 23 | 16 |
| Reason not given | 3 | 1 |
| Adverse Event | 129 | 122 |
| Lost to Follow-up | 210 | 198 |
| Not treated | 25 | 17 |
Analysis population for the primary outcome, as defined in the registry: Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.
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 | Acetylsalicylic Acid (Aspirin, BAYE4465) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 6270 | 6276 | 12546 | |
| Age, Continuous | Years | 63.9 (SD 7.10) | 63.9 (SD 7.05) | 63.9 (SD 7.08) |
| Sex: Female, Male: Female | Participants | 1851 | 1857 | 3708 |
| Sex: Female, Male: Male | Participants | 4419 | 4419 | 8838 |
6. Primary Endpoint
The registry lists the primary outcome as Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack), measured over Until follow-up (approximate 6 years).
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is time from randomization to the first confirmed occurrence of myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack. The event date was defined as the date of an event confirmed by adjudication. The endpoint therefore combines the identity of the first qualifying event with the time elapsed from randomization to that event.
Time-to-first-event endpoints are used when the timing of an event matters as well as whether it occurred. In general, this approach can use information about how long participants remain under observation without a recorded event, rather than reducing follow-up to a simple event/no-event label. It also avoids counting later events in the same person as separate primary events once a first event has occurred. These are general features of the endpoint type, not findings about this trial.
The record says that Kaplan-Meier analyses were used to estimate the number of days by which 1%, 2%, 3%, and 4% of participants had reached endpoint events. These are event-timing milestones, not treatment-effect estimates by themselves. The record does not provide the estimated milestone times, group-specific event counts, or a comparative measure such as a hazard ratio or risk difference. It therefore describes what the primary endpoint measures, but does not allow the magnitude or precision of the group comparison to be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question, design, treatment regimens, and primary endpoint. It does not report the comparative primary-outcome results. In particular, it gives no group-specific primary-event counts, time-to-event estimates, effect estimate, confidence interval, or p-value. Without those results, the direction, size, and statistical precision of the primary comparison cannot be determined from the record.
The endpoint is a composite of confirmed myocardial infarction, stroke, cardiovascular death, unstable angina, and transient ischemic attack. A composite can provide a broader measure of first events, but its overall result may reflect contributions from components that occur at different rates or have different clinical importance. Component-specific results would be needed to understand which events contributed to any overall difference. The listed secondary outcomes include the time to first occurrence of the composite of cardiovascular death, myocardial infarction, or stroke, and outcomes for individual components and other conditions. Their results are not reported in the registry record.
In general, a time-to-event estimate describes the timing of events while accounting for the time participants remain under observation. The record identifies Kaplan-Meier analyses for the specified event milestones, but it does not provide the estimates or describe how censoring was handled. No group comparison can be inferred merely from the choice of method. Nor does the trial’s completed status establish whether the primary endpoint favored either group.
The enrollment total is 12546, and the intention-to-treat population is described as all randomized participants. This identifies the stated analysis population, but it does not establish how many participants had complete endpoint follow-up, whether any were excluded from an analysis, or how missing outcome information was addressed. Those details are not reported in the registry record.
The adverse-event counts are descriptive safety information and do not fill the gap in the primary efficacy results. The posted counts of participants with serious adverse events are 1311 in the placebo group and 1266 in the acetylsalicylic acid group. The counts for other adverse events are 5053 and 5059, respectively. These figures alone do not provide a comparative estimate adjusted for follow-up time, establish whether events were judged treatment-related, or describe the severity and timing of every event. The registry record does not report deaths in the adverse-event group data.
In general, estimates should be read together with their uncertainty. A confidence interval describes a range of effect estimates compatible with the data and model at a stated confidence level; its width indicates precision, while its position relative to a no-difference value helps interpret the evidence. A p-value, when reported, describes how incompatible the data are with a specified null model under its assumptions; it is not the probability that a treatment effect is absent. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record. Consequently, a statistical conclusion about that comparison is not supported by the information available.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure, with time counted in days from randomization to the first adjudicated qualifying event. The listed endpoint events are myocardial infarction, stroke, cardiovascular death, unstable angina, and transient ischemic attack. The record states that Kaplan-Meier analyses estimated the days by which 1%, 2%, 3%, and 4% of participants had reached endpoint events. It does not report those milestone estimates or the method used to compare the randomized groups.
What does a time-to-event analysis describe?
In general, time-to-event analysis uses both whether an event is observed and how long each person is followed. A participant without a recorded event by the end of observation contributes information up to that point; such observation is commonly described as censored. This differs from treating every participant without a recorded event as if they had experienced the same complete follow-up. The record does not report how censoring was defined or handled in this trial, so no particular procedure beyond the stated Kaplan-Meier milestone estimation should be assumed.
Kaplan-Meier methods generally estimate the proportion of participants remaining free of the event over time, using observed event times and accounting for censored observations under assumptions about censoring. The stated milestones express when estimated cumulative event proportions reached specified levels. They are descriptive timing summaries. By themselves, milestone times do not show the size or precision of a treatment-group contrast, and the record contains no actual milestone values.
What is the role of the composite endpoint?
A composite endpoint treats the first occurrence of any listed component as the primary event. In general, this can increase the number of events available for analysis and can capture more than one kind of clinically relevant outcome. It also means that the combined result may be influenced more by components that occur more often. Component-level results are useful for understanding the composition of a composite, but the registry record does not report results for the primary components. The listed secondary outcomes include analyses of individual components and other cardiovascular outcomes, but their numerical findings are not reported.
What does intention-to-treat mean?
The record defines the intention-to-treat group as all patients randomized to the assigned study drug, with N=12546. In general, intention-to-treat analysis compares participants according to their randomized assignment, regardless of later adherence or treatment changes, when those data are analyzed. This preserves the original randomized comparison and estimates the effect of assignment under trial conditions. The record identifies the population but does not give the number included in each primary analysis, describe adherence, or state how missing endpoint data were addressed.
How should uncertainty be considered?
General statistical interpretation relies on the estimate and its uncertainty, not only on whether a result crosses a significance threshold. A confidence interval communicates the precision of an estimate under a statistical model: narrower intervals indicate more precision, while wider intervals indicate less. A p-value summarizes how unusual the data would be under a specified null hypothesis and model assumptions. These quantities do not substitute for the estimated effect or its clinical interpretation. The registry record does not report a primary-outcome effect estimate, confidence interval, or p-value, so their interpretation is not possible for this comparison.
What does multiplicity change?
When an analysis includes multiple outcomes, components, time points, or comparisons, the chance of at least one apparently unusual result can increase if each is tested separately without adjustment. General approaches to multiplicity include prespecifying a hierarchy of tests or adjusting thresholds or intervals. The record lists 9 outcome measures and 27 analyses, but does not report a multiplicity strategy or the analysis hierarchy. It would therefore be inappropriate to infer that a particular correction was used or that all reported tests, if any, had the same confirmatory status.
How should planning illustrations be read?
General sample-size calculations depend on design assumptions, the effect selected for detection, the significance level, allocation, and the statistical approximation used. The planning description states a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; it describes the effect to detect as a stated fraction of an observed effect. It also distinguishes total events for time-to-event calculations from participants per arm for other calculations. Such calculations are planning illustrations, not observed power and not a record of the trial’s original design justification. The record does not report a protocol-based sample-size rationale, and no numerical planning result should be treated as an observed trial result.
Over-dispersion is a general concern when count outcomes vary more than a simple model expects; ignoring it can make uncertainty estimates too optimistic. The primary endpoint is described as time to a first event, not as a count of repeated events, and no dispersion estimate is reported. It would not be appropriate to apply an over-dispersion interpretation to this endpoint without further information about the analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 9 outcome measures and 27 analyses. The primary endpoint is a composite time-to-first-event outcome; secondary outcomes include a composite of cardiovascular death, myocardial infarction, or stroke, individual components, all-cause mortality, and cancer outcomes. The record does not report the prespecified testing hierarchy, whether secondary analyses were confirmatory or exploratory, or whether any adjustment for multiple comparisons was used. When many outcomes or analyses are examined, general statistical practice treats isolated findings cautiously unless their role and multiplicity plan are clear.
The stated primary analysis population is intention-to-treat: all patients randomized to the assigned study drug, with N=12546. The record does not report the number with observed primary endpoint data, the number included in each analysis, or the handling of participants with incomplete follow-up. It also does not describe imputation, sensitivity analyses for missing outcomes, or assumptions about loss to follow-up. These omissions matter because time-to-event estimates depend on follow-up and on how observations without a recorded event are treated.
The record does not report whether the primary analysis was adjusted for baseline variables, how protocol deviations were handled, or whether there were additional analysis populations. It also does not provide an analysis plan or identify interim analyses and stopping boundaries. The study summary mentions an independent Data Safety Monitoring Board, but does not report its review schedule or whether it reviewed interim efficacy data. These details should not be guessed from the completed status or from the trial design description.
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 |
|---|---|---|---|
| Placebo | 1311 | 6276 | 20.9% |
| Acetylsalicylic Acid | 1266 | 6270 | 20.2% |
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 |
|---|---|
| Placebo | 5053 of 6276 |
| Acetylsalicylic Acid | 5059 of 6270 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Acetylsalicylic Acid |
|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 103 of 6276 | 104 of 6270 |
| Coronary artery disease | Cardiac disorders | 61 of 6276 | 46 of 6270 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 44 of 6276 | 59 of 6270 |
| Acute myocardial infarction | Cardiac disorders | 58 of 6276 | 43 of 6270 |
| Atrial fibrillation | Cardiac disorders | 40 of 6276 | 37 of 6270 |
| Myocardial infarction | Cardiac disorders | 38 of 6276 | 29 of 6270 |
| Inguinal hernia | Gastrointestinal disorders | 31 of 6276 | 35 of 6270 |
| Transient ischaemic attack | Nervous system disorders | 30 of 6276 | 26 of 6270 |
| Pneumonia | Infections and infestations | 19 of 6276 | 26 of 6270 |
| Chest pain | General disorders | 19 of 6276 | 23 of 6270 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Acetylsalicylic Acid |
|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | 688 of 6276 | 695 of 6270 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 653 of 6276 | 636 of 6270 |
| Bronchitis | Infections and infestations | 482 of 6276 | 514 of 6270 |
| Hypertension | Vascular disorders | 514 of 6276 | 478 of 6270 |
| Cough | Respiratory, thoracic and mediastinal disorders | 497 of 6276 | 442 of 6270 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 423 of 6276 | 468 of 6270 |
| Nasopharyngitis | Infections and infestations | 407 of 6276 | 421 of 6270 |
| Lower respiratory tract infection | Infections and infestations | 420 of 6276 | 377 of 6270 |
| Dyspepsia | Gastrointestinal disorders | 362 of 6276 | 374 of 6270 |
| Upper respiratory tract infection | Infections and infestations | 371 of 6276 | 348 of 6270 |
Serious events with the highest arm-level rate: osteoarthritis (1.7%), coronary artery disease (1.0%), prostate cancer (0.9%), acute myocardial infarction (0.9%), atrial fibrillation (0.6%).
The adverse-event figures are counts of participants affected in the two study groups. In the placebo group, 1311 of 6276 participants are listed as affected by serious adverse events, and 5053 of 6276 are listed as affected by other adverse events. In the acetylsalicylic acid group, the corresponding counts are 1266 of 6270 for serious adverse events and 5059 of 6270 for other adverse events. These are posted counts, not adjusted comparisons. No new percentages or between-group calculations are made.
The registry lists serious-event terms including osteoarthritis (1.7%), coronary artery disease (1.0%), prostate cancer (0.9%), acute myocardial infarction (0.9%), atrial fibrillation (0.6%), and myocardial infarction (0.6%). The record does not specify the denominator or group allocation for these term percentages in the information available, so they should not be interpreted as group-specific rates. It also does not report whether events were judged related to study treatment, how recurrent events were counted, or the duration of observation underlying the counts. Deaths are not reported in the adverse-event group data. These safety summaries describe recorded events; they do not, by themselves, establish a causal treatment effect or provide a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed randomized, placebo-controlled study evaluated daily 100 mg enteric-coated acetylsalicylic acid in a population described as being at moderate cardiovascular risk and without known cardiovascular disease. Its primary outcome was the time to the first adjudicated occurrence of myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack. The study was intended to assess efficacy and safety in a standard-care setting, with risk-factor treatment left to the treating physician.
What the record does not establish is the result of the primary comparison. There is no reported group-specific primary-event count, event-time estimate, effect estimate, confidence interval, or p-value. As a result, the direction and magnitude of any group difference and the precision of that difference cannot be determined. The record’s completed status and stated purpose are not substitutes for the outcome results.
The reported adverse-event counts offer limited descriptive information. They do not show whether an event was caused by treatment, account for different follow-up durations, or provide a comparative analysis. The list of serious-event terms also lacks a reported denominator and group-specific breakdown in the information available. These figures should not be taken as evidence of benefit or harm without fuller results and appropriate comparative analyses.
More generally, a trial’s findings apply most directly to its enrolled population, interventions, comparator, follow-up, and outcome definitions. The summary describes a specific moderate-risk population, one daily tablet of each assigned treatment, and follow-up of approximately 6 years. It does not provide enough information to judge how closely an individual patient or another population matches the enrolled group, nor does it report the trial’s primary results. The appropriate statistical conclusion from the registry record is therefore limited: the design and endpoint are described, but the primary treatment-effect evidence is not reported.
13. Why This Trial Matters Statistically
This study is statistically notable for framing a primary-prevention question around a time-to-first-event composite in a population described as having moderate cardiovascular risk. The outcome combines several kinds of cardiovascular events, while the stated analysis focuses on when the first qualifying event occurred. That design choice makes event timing central to the research question rather than treating follow-up as a simple final event/no-event status.
The record also describes an intention-to-treat population of 12546 randomized participants and reports Kaplan-Meier estimation of the time by which 1%, 2%, 3%, and 4% of participants had reached the primary endpoint. These details identify the intended population and a time-to-event summary approach. They do not, without the numerical endpoint results and uncertainty estimates, establish how the groups compared.
Statistically, the composite endpoint and the listed secondary outcomes raise questions about how component results and multiplicity should be interpreted. A combined endpoint can summarize first events across several components, while component-specific outcomes can help clarify what contributes to that summary. The registry record lists multiple measures and analyses but does not report the testing hierarchy or multiplicity strategy. Nor does it report the primary comparative estimate, so the record cannot support a conclusion about the treatment effect.
The study also illustrates why design information and results must be distinguished. Randomization, masking, adjudication, and a specified analysis population describe methods intended to support a fair comparison. They do not replace the observed results, their uncertainty, or information about missing follow-up. In this case, the methods description is useful for understanding the question, but the primary findings needed for statistical interpretation are not reported in the registry record.
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.
The central limitation for interpreting this trial record is that the primary-outcome results are not reported. The endpoint definition is detailed, but the record contains no primary-event counts by group, milestone times, comparative effect estimate, confidence interval, or p-value. The study’s status is completed, yet completion alone cannot reveal the direction, size, or precision of its findings.
The record does not report actual follow-up duration by group or participant, the number of participants with complete endpoint ascertainment, or how censored observations and missing outcome data were handled. These details are particularly relevant to a time-to-event endpoint. The summary mentions adjudication, but the adjudication process and any agreement or quality-control information are not described.
The composite endpoint includes myocardial infarction, stroke, cardiovascular death, unstable angina, and transient ischemic attack. The record does not provide primary component results, so any contribution by individual outcomes cannot be assessed. Although secondary outcomes and analyses are listed, their results, statistical hierarchy, and multiplicity procedures are not reported.
The record identifies triple masking and an official title that describes the study as double-blind, without explaining the difference or identifying who was masked. It mentions a Data Safety Monitoring Board but does not report interim analyses or board decisions. The study summary allows usual treatment of underlying risk factors at the treating physician’s discretion, but does not describe those treatments or their balance between groups.
Safety information is also incomplete for comparative interpretation: deaths are not reported in the adverse-event group data, the term-level serious-event percentages lack a stated denominator and group-specific breakdown, and the record does not describe event attribution or follow-up time for these counts. Finally, the protocol’s sample-size justification and full statistical analysis plan are not reported. These gaps limit assessment of both the efficacy analysis and the completeness of safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease — NCT00501059.
- Registry record last updated 2018-10-26; status last verified 2018-09.
- Results first posted 2018-01-08.
- 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
The registry record describes NCT00501059, a completed Phase 3 randomized, parallel-group, placebo-controlled study sponsored by Bayer. It enrolled 12546 participants described as being at moderate cardiovascular risk and without a history of known cardiovascular disease. Participants received one 100 mg enteric-coated acetylsalicylic acid tablet or one matching placebo tablet orally once daily, alongside standard care.
The primary endpoint was time from randomization to the first adjudicated occurrence of myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack. The record identifies an intention-to-treat population and Kaplan-Meier estimation of event-time milestones. It lists secondary outcomes and adverse-event counts, but does not report a comparative primary-outcome result, its uncertainty, or key details on missing data and multiplicity. Therefore the design can be described, but the primary treatment-effect findings cannot be interpreted from the registry record.