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 Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study (NCT02576067), a randomized phase 3 study. The primary outcome is Change in Arterial Inflammation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02576067 |
| Phase | Phase 3 |
| Condition | Vascular Inflammation, Atherosclerotic Cardiovascular Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 123 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned a subset of participants in the main Cardiovascular Inflammation Reduction Trial. The main trial population described in the registry had a prior myocardial infarction or angiographically demonstrated multivessel coronary artery disease. The imaging study addressed vascular inflammation in people with atherosclerotic cardiovascular disease; the specific eligibility criteria for the imaging subset are not reported in the registry record.
Intervention
Participants were assigned to low dose methotrexate. The intervention description gives an average dose of 15-20 mg po/weekly. The study proposed serial 18FDG-PET/CT imaging, with baseline imaging and follow-up imaging approximately 8 months later.
Comparator
The comparison group received matching placebo. The study was randomized, double-blind, and parallel, according to the registry record.
Primary question
The primary question was whether the relative change in arterial inflammation from baseline to 8 months, assessed using the most diseased segment of the index vessel, differed between low dose methotrexate and placebo. The posted primary outcome is expressed as percent change and summarized using a median and interquartile range. The registry describes a hypothesis of reduced plaque inflammation with methotrexate; that hypothesis is not itself evidence that a reduction occurred.
This is an ancillary imaging study, rather than a report of the full clinical outcomes question of the main CIRT trial. Its focus is a PET/CT measure of arterial inflammation. The registry record describes that measure as a way to visualize vascular inflammation over time. The results therefore address the selected imaging endpoint, not cardiovascular morbidity or mortality. The available record does not report enough detail to determine how the imaging subset was selected from the main trial or how representative it was of the main trial population.
3. Trial Design
The Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study is registered as a Phase 3, randomized, double-blind, parallel study. The registry lists an enrollment of 123 and a completed status. The study dates recorded are 2015-12-18 for start and 2019-03-29 for primary completion. These dates describe the registry record; they do not, by themselves, explain when each participant was enrolled or imaged.
The imaging study was ancillary to the main CIRT trial. Its stated approach was to obtain baseline FDG-PET/CT imaging after participants entered the main trial and follow-up imaging approximately 8 months later. Imaging data were to be acquired and analyzed centrally, with results incorporated into the main CIRT database. The registry does not report the imaging protocol details, the central reading procedures, or how image quality and unreadable scans were handled.
The two intervention groups were low dose methotrexate and matching placebo. The primary endpoint results list 26 participants for low dose methotrexate and 27 for placebo. The safety results use different at-risk counts: 60 for low dose methotrexate and 63 for placebo. These outcome-specific counts should not be treated as interchangeable. The registry does not explain the difference between the enrollment figure and the numbers contributing to the endpoint or safety summaries.
Randomization and double masking describe important design protections, but the registry record does not report the allocation sequence method, concealment procedures, or who was masked. It also does not report whether the analysis followed the original randomized assignments, how departures from assigned treatment were handled, or whether any interim analyses were performed. Those details cannot be inferred from the design labels alone.
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 | Low Dose Methotrexate | Placebo |
|---|---|---|
| STARTED | 60 | 63 |
| COMPLETED | 26 | 27 |
| NOT COMPLETED | 34 | 36 |
Reasons for not completing this period:
| Reason | Low Dose Methotrexate | Placebo |
|---|---|---|
| Death | 0 | 1 |
| Lack of Efficacy | 1 | 0 |
| Lost to Follow-up | 11 | 0 |
| Withdrawal by Subject | 11 | 2 |
| study closure of main CIRT trial) | 0 | 8 |
| not randomized, failed run-in | 7 | 0 |
| screen failure/ re-enrolled | 0 | 25 |
| Physician Decision | 4 | 0 |
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 | Low Dose Methotrexate | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 26 | 27 | 53 | |
| Age, Continuous | years | 63 (61 to 67) | 65 (59 to 71) | 64 (59 to 71) |
| Sex: Female, Male: Female | Participants | 4 | 3 | 7 |
| Sex: Female, Male: Male | Participants | 22 | 24 | 46 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 4 | 7 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 | 23 | 46 |
| 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 | 5 | 3 | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): White | Participants | 18 | 20 | 38 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| hs-CRP | mg/L | 1.4 (0.7 to 2.1) | 1.1 (0.7 to 2.1) | 1.3 (0.7 to 2.1) |
| Total Cholesterol | mg/dL | 138.1 (108 to 160) | 131 (112 to 158) | 134 (108 to 160) |
| LDL cholesterol | mg/dL | 63 (49 to 84) | 66 (45.2 to 82) | 64 (45 to 84) |
| HDL cholesterol | mg/dL | 42.5 (38 to 50) | 40 (36.3 to 47) | 41.5 (36 to 50) |
| MDS TBR Index Vessel | ratio | 2.46 (2.15 to 2.77) | 2.41 (2.06 to 2.75) | 2.44 (2.06 to 2.77) |
| TMNMX MDS: LCC - left common carotid | ratio | 2.04 (1.89 to 2.29) | 2.12 (1.85 to 2.46) | 2.08 (1.85 to 2.46) |
| TMNMX MDS: RCC - right common carotid | ratio | 2.12 (2.04 to 2.48) | 2.13 (1.99 to 2.36) | 2.12 (1.99 to 2.48) |
| TMNMX MDS: ATA - ascending thoracic aorta | ratio | 2.45 (2.08 to 2.72) | 2.22 (1.97 to 2.71) | 2.34 (1.97 to 2.72) |
| TMNMX: Combined Carotid | ratio | 1.93 (1.75 to 2.22) | 1.93 (1.77 to 2.24) | 1.93 (1.75 to 2.24) |
| TMNMX: ATA | ratio | 2.34 (1.98 to 2.53) | 2.12 (1.92 to 2.58) | 2.23 (1.92 to 2.58) |
| SMNMX: Combined Carotid | ratio | 1.82 (1.63 to 2.20) | 1.78 (1.52 to 1.95) | 1.80 (1.52 to 2.20) |
| SMNMX: ATA | ratio | 2.26 (1.95 to 2.53) | 2.24 (2.04 to 2.46) | 2.25 (1.95 to 2.53) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Arterial Inflammation, measured over baseline and 8 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | percent change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in arterial inflammation, measured as the relative change at 8 months compared with baseline. The measure uses the most diseased segment, or MDS, of an index vessel. The registry defines the MDS as a 1.5 cm segment within the right or left carotid artery with the highest PET/CT activity. It is calculated as a mean of maximum target-to-background ratio values from 3 contiguous axial segments. The index vessel is the aorta, right carotid, or left carotid with the greatest mean target-to-background ratio at baseline.
The endpoint is intended to capture change in PET/CT activity in a particularly active arterial segment, rather than a clinical event such as myocardial infarction. The registry identifies the measurement as a percent change and states that it is summarized by the median and interquartile range. The reported endpoint value is 0.03 for low dose methotrexate and 0.2 for placebo. The record does not include the interquartile range values. It also does not clarify in the endpoint description how to interpret a positive versus negative change on the recorded scale.
As a general statistical point, a repeated imaging measure can describe change over time in a biological marker, but that does not make it a direct measure of clinical benefit. The result is specific to the endpoint definition, the imaging method, and the participants with endpoint data. Other outcomes, including the listed changes in maximum target-to-background ratio and maximum target-to-background ratio within the carotid arteries, are secondary outcomes and should not be substituted for the primary measure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary endpoint estimate is 0.03 for low dose methotrexate and 0.2 for placebo. The endpoint is defined as a relative change from baseline and summarized as a median. The registry also gives accompanying lower and upper values: -0.19 and 0.3 for low dose methotrexate, and -0.06 and 0.42 for placebo. It does not identify the meaning of these lower and upper values in the record available for this analysis, so they should not be described as confidence intervals or as interquartile ranges. The interquartile range is named as the dispersion measure, but its values are not reported in the registry record.
The reported endpoint values are not a direct comparison estimate with an accompanying test of the treatment contrast. The registry lists no analyses, and the posted results do not report a p-value, a treatment-effect estimate for the between-group contrast, or a confidence interval for that contrast. The reported values alone do not establish whether a difference between groups is compatible with no difference or with a meaningful difference. In particular, a visual comparison of group summaries cannot replace an analysis that accounts for variability and the study’s analysis population.
The lower and upper values for both groups extend across zero. This describes the displayed values, but without knowing what those values represent, it does not provide a formal test of change or treatment effect. Nor does it determine whether either group’s change is statistically distinguishable from zero. Any inference about the comparative effect would require a defined contrast and its uncertainty, neither of which is reported in the registry record.
The endpoint results include 26 participants in the methotrexate group and 27 in the placebo group. These are the counts associated with the primary result, not the registry’s overall enrollment figure. Why the primary endpoint counts differ from the enrollment and safety counts is not reported in the registry record. Missing endpoint values, reasons for missingness, and handling of incomplete imaging are also not reported. These omissions matter because an imaging endpoint can be available only for participants with usable baseline and follow-up measurements.
General statistical interpretation: a point estimate is a summary of observed data, while an uncertainty interval describes how imprecisely an estimate is measured under a specified method. A treatment comparison generally needs an estimate of the between-group contrast and its uncertainty. When only separate group summaries are posted, those summaries do not supply the uncertainty of the contrast or the details of an adjusted analysis. The registry’s own analysis takes precedence when available; no such analysis is listed in this record.
The registry’s stated hypothesis anticipated a decrease in plaque inflammation with low dose methotrexate relative to placebo. The posted outcome summaries should be read as the recorded group-level results, not as confirmation of that hypothesis. They do not report evidence about cardiovascular morbidity or mortality, and they do not establish how the imaging findings relate to clinical outcomes.
9. Statistical Methods Explained
What does randomization contribute?
Randomization is intended to make assigned groups comparable, on average, with respect to characteristics that could influence an outcome. It reduces the risk that treatment assignment is systematically linked to measured or unmeasured prognostic factors. It does not guarantee that the groups will be identical, especially in an ancillary imaging sample, and it does not remove the need to define who was included in the analysis. The registry labels this study randomized, but does not describe the randomization method, allocation concealment, or analysis population.
What does double masking mean?
Double masking is intended to limit the influence of treatment knowledge on behavior, outcome assessment, and reporting. The registry identifies the study as double-masked and describes a matching placebo. It does not specify which roles were masked or how masking was maintained. Central analysis of imaging data was proposed in the study description, but the registry does not report reader procedures or whether image assessors remained unaware of assignment.
How should a median be read?
General statistical explanation: the median is the middle of the ordered observations and is less affected by extreme observations than the arithmetic mean. It is useful when an outcome is skewed or when unusually high or low measurements could pull a mean away from the typical observation. The registry identifies the primary endpoint summary as a median with an interquartile range. The posted result includes a value for each group, but the interquartile range values are not reported in the registry record. A median by itself does not show the spread of individual participant results.
The endpoint is a relative change in an imaging measure between baseline and follow-up. General statistical explanation: change scores are interpretable only in relation to how the measure is defined, the scale on which it is recorded, and the way baseline values enter the calculation. A group median change is not the same quantity as a treatment contrast. A direct comparison should estimate how the outcome differs between assigned groups and quantify uncertainty in that difference. The registry does not report such a contrast or an analysis test.
Why does over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates can be too narrow and its tests can appear more decisive than warranted. The appropriate response depends on the outcome scale and model. The registry record does not report a model for the primary endpoint, so there is no basis for assessing whether over-dispersion was evaluated or how it was addressed. For a median-based summary, the distribution and spread of individual observations still matter even when a specific model is not named.
What does a confidence interval communicate?
General statistical explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical procedure. Its interpretation depends on the estimand, model, and method used to construct it. The registry lists lower and upper values alongside each group estimate, but does not identify their statistical meaning. They therefore should not be relabeled as confidence intervals. Separate group intervals, if that is what they were, would not automatically equal an interval for the between-group contrast.
How should the planning illustrations be understood?
The registry record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning calculations, not results from additional participants and not evidence about the probability that the trial detected an effect. A sample-size calculation asks what study size would be needed under specified assumptions for a chosen target; it does not establish that those assumptions hold. The record does not identify these illustrations as the trial’s original design justification, and they should not be treated as the trial’s own planned sample size.
In general, planning for a fraction of an observed effect asks what size a future study might require if the target effect were smaller than the observed estimate. Such illustrations are sensitive to the observed estimate, outcome variability, analysis method, and assumptions about allocation and significance level. The registry record does not report the original sample-size justification or a prospective target effect for this imaging study. The illustrations cannot fill that gap.
What can be learned from the posted analysis information?
The record lists 3 outcome measures and 2 secondary outcomes, but no analyses are listed. The primary endpoint is described, and group-level results are posted, but the analysis method used to compare groups is not reported in the registry record. The record also does not report adjustment for baseline values, covariates, or multiple outcome testing. It is therefore not possible to determine whether the posted group summaries came from a prespecified analysis or to assess how the treatment comparison was planned.
General statistical explanation: an analysis plan specifies the outcome definition, analysis population, model or summary method, treatment contrast, handling of missing observations, and approach to multiple testing. Prespecification helps distinguish planned analyses from choices made after results are known. The registry record does not supply those details. That absence does not prove that no plan existed; it means that the plan cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures, including the primary endpoint and 2 secondary outcomes: change in maximum target-to-background ratio and change in maximum target-to-background ratio within the carotid arteries. It lists no analyses. The method used to compare the groups for these outcomes, and whether any adjustment for multiple testing was planned or applied, are not reported in the registry record.
General statistical explanation: when several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if each is assessed separately without accounting for the collection of tests. A multiplicity strategy can prioritize a primary outcome, adjust testing thresholds, or use another prespecified approach. The registry identifies a primary endpoint, but that alone does not reveal whether or how secondary outcomes were handled in a formal testing plan. No multiplicity procedure is reported.
The primary endpoint results list 26 participants for low dose methotrexate and 27 for placebo. The safety summaries list 60 and 63 at risk, respectively, while overall enrollment is 123. The registry does not explain the relationship among those counts. Reasons for unavailable imaging, missing baseline or follow-up measurements, and any imputation or other missing-data method are not reported in the registry record.
The analysis population is not reported in the registry record. It is therefore unclear whether the endpoint summaries include all participants assigned to the groups, only participants with usable imaging at both time points, or another defined set. The registry also does not state how treatment discontinuation, nonadherence, or protocol deviations were handled. These details affect how broadly the endpoint summaries can be interpreted.
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 |
|---|---|---|---|
| Low Dose Methotrexate | 0 | 60 | 0.0% |
| Placebo | 0 | 63 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Low Dose Methotrexate | 1 of 60 |
| Placebo | 1 of 63 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Low Dose Methotrexate | 1 of 60 |
| Placebo | 1 of 63 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Low Dose Methotrexate | Placebo |
|---|---|---|---|
| Missinjected dose (isotope) | Investigations | 1 of 60 | 1 of 63 |
The serious adverse event summaries list 0 affected participants in each group: the low dose methotrexate group had 60 at risk, and the placebo group had 63 at risk. The record also lists 1 other adverse event in each group and 1 death in each group. The registry does not provide serious adverse event terms, and the list of top serious terms is empty.
These categories should be read as separate posted counts. The record does not say whether the other adverse events or deaths were related to treatment, whether events overlapped across categories, or when they occurred. It also does not provide event descriptions or a detailed safety analysis. The counts do not support a conclusion about cause, comparative risk, or the overall safety profile.
The at-risk counts used for these summaries differ from the counts reported with the primary imaging endpoint. They are outcome-specific denominators and should not be substituted for the endpoint counts. General statistical explanation: safety counts are most informative when the event definition, observation period, denominator, and handling of repeat events are clear. Those details are not reported in the registry record, so interpretation should remain limited to the categories and counts that are posted.
12. What the Result Does, and Does Not, Mean
The registry reports a median primary endpoint value of 0.03 for low dose methotrexate and 0.2 for placebo, for a measure defined as relative change in arterial inflammation from baseline to 8 months. It also gives lower and upper values for each group, but does not label their statistical meaning. The posted result therefore offers group-level descriptive information, but not a documented treatment-effect estimate with uncertainty for the comparison between groups.
The result does not establish whether methotrexate changed arterial inflammation relative to placebo. The registry does not list a statistical comparison, p-value, or confidence interval for the between-group contrast. The endpoint’s dispersion measure is named as the interquartile range, but those values are not reported in the registry record. Nor does the record provide enough information to judge the extent or handling of missing imaging data.
The primary endpoint is an imaging measure, not a cardiovascular event outcome. The registry describes the main CIRT question as addressing cardiovascular morbidity and mortality, but this ancillary imaging study’s primary endpoint is PET/CT activity in an arterial segment. The posted imaging results do not answer whether treatment affects cardiovascular morbidity or mortality, and they do not establish that a change in the imaging measure would correspond to a change in clinical outcomes.
General statistical explanation: a biomarker can be biologically relevant without being a validated substitute for a clinical outcome. A treatment effect on a biomarker and a treatment effect on a clinical event are distinct questions. The strength of any connection between them requires evidence beyond a group summary of the biomarker. The registry record does not report that kind of validation analysis for this study.
The record also does not provide the original statistical analysis plan, the imaging-subset selection process, or the reasons that endpoint and safety counts differ. Consequently, the result should be interpreted narrowly: it describes the posted endpoint summaries for the participants included in those summaries. It does not, on its own, establish a causal effect, resolve uncertainty about missing measurements, or answer questions beyond the stated imaging endpoint.
13. Why This Trial Matters Statistically
This study illustrates a common challenge in clinical research: a biological mechanism may be investigated using a specialized measurement before or alongside clinical outcomes. Here, the stated aim was to use serial FDG-PET/CT imaging to visualize vascular inflammation in an ancillary subset of the main CIRT trial. The design links a treatment comparison to a defined arterial imaging measure, making the endpoint and its measurement process central to interpretation.
It also demonstrates why a registry result needs more than group summaries for a strong comparative interpretation. The primary outcome is identified as a median percent change, and group estimates are posted, but the record does not report the treatment contrast, analysis method, uncertainty for that contrast, or analysis population. Without those details, readers cannot determine how precisely the group difference is estimated or how the analysis accounted for the design and available data.
The differing endpoint and safety counts further underscore the importance of outcome-specific denominators. An enrollment number does not explain how many participants contributed usable data to every outcome. Transparent reporting of participant flow, missing measurements, and analysis populations would help readers understand why denominators vary and how the results apply to the enrolled group.
Finally, the study distinguishes an imaging endpoint from the clinical question motivating the main trial. Measuring change in PET/CT activity can address a mechanistic question, but it is not equivalent to measuring morbidity or mortality. Keeping those questions separate prevents a biomarker result from being interpreted as a clinical outcome result. This is a statistical lesson about estimands, measurement, and evidence scope, rather than a conclusion about treatment.
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 registry record does not report the imaging-subset eligibility criteria or selection process. Although the study is described as involving a subset of main-trial participants, it is not possible to assess from the record how that subset was formed or how it relates to the larger trial population. The enrollment figure, primary endpoint counts, and safety at-risk counts are different, and their relationship is not explained.
The primary endpoint description is detailed about the MDS and index vessel, but the registry does not report the full imaging acquisition and reading procedures. It does not specify how technically inadequate scans, missing baseline or follow-up scans, or changes in the selected vessel were handled. The interquartile range values are also absent, and the lower and upper values accompanying each group estimate are not identified statistically.
The record does not report a between-group analysis, an analysis population, adjustment for baseline values, or a missing-data method. The allocation and masking methods are not described beyond the design labels. No statistical analysis plan, original sample-size justification, or interim-analysis information is reported in the registry record.
The registry lists secondary outcomes but no analyses, and it does not report a multiplicity strategy. It also does not provide clinical outcome results for this imaging endpoint. These limitations restrict interpretation to the posted group summaries and preclude a detailed assessment of comparative precision, robustness, or generalizability. They do not show that unreported procedures were absent; they indicate that those procedures cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study — NCT02576067.
- Registry record last updated 2020-04-20; status last verified 2020-04.
- Results first posted 2020-04-20.
- 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 a completed, randomized, double-blind, parallel Phase 3 ancillary imaging study of low dose methotrexate versus matching placebo. It lists enrollment of 123 and primary completion on 2019-03-29. The primary outcome is relative change in arterial inflammation from baseline to 8 months, based on the most diseased segment of the index vessel.
The posted median endpoint values are 0.03 for low dose methotrexate and 0.2 for placebo. The endpoint results list 26 and 27 participants, respectively. The safety summaries report 0 serious adverse events in each group, 1 other adverse event in each group, and 1 death in each group. The registry lists 2 secondary outcomes and no analyses.
A treatment contrast, its statistical uncertainty, the interquartile range values, the analysis population, and missing-data handling are not reported in the registry record. The posted summaries therefore describe the recorded endpoint and safety results, but do not establish a comparative treatment effect or answer the main trial’s clinical outcome question.