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 Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke (NCT01464307), a randomized phase 3 study. The primary outcome is Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01464307 |
| Phase | Phase 3 |
| Condition | Post-stroke Spasticity of the Lower Limb |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 290 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merz Pharmaceuticals GmbH |
| Results posted | Yes |
2. Clinical Question
Population
People with post-stroke spasticity of the lower limb. The primary analysis population was the Full Analysis Set: participants in the Safety Evaluation Set for the main period whose primary efficacy variable was available. The Safety Evaluation Set included participants exposed to investigational product at least once during the main period.
Intervention
IncobotulinumtoxinA, also identified as Xeomin or NT 201, at 400 Units. The study description concerns injections into leg muscles.
Comparator
Placebo to incobotulinumtoxinA. The randomized main-period comparison was between the active treatment and placebo.
Primary question
Did change from baseline in the Ashworth Scale for plantar flexors at Week 4 differ between the incobotulinumtoxinA and placebo groups? The registry record states the question and endpoint, but the numerical arm results and treatment contrast are not reported in the registry record.
The study addresses muscle stiffness after stroke, focusing on resistance to passive movement in the plantar flexors. The Ashworth Scale is described as a commonly used clinical measure in spasticity trials and as a way to categorize severity through the resistance encountered during passive movement.
The clinical question is about a group-level change in a rating scale over the stated assessment period. It is not, by itself, a question about every participant’s experience, sustained effects beyond the specified visit, or outcomes in other muscles. The record also names response rate at post-baseline visits and Ashworth Scale values at post-baseline visits as secondary outcomes. Those outcomes broaden the set of questions considered, but their numerical results are not reported in the registry record.
3. Trial Design
This was a Phase 3, randomized, parallel-group study with quadruple masking and placebo control. The registry record lists an enrollment of 290. Its official title describes a prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label extension period. The main-period comparison was incobotulinumtoxinA (Xeomin) 400 Units versus placebo.
The record identifies the study population as people with post-stroke spasticity of the lower limb. The active intervention is described as powder for solution for injection, and the placebo as a matching placebo to incobotulinumtoxinA powder for solution for injection. The study purpose was to investigate efficacy and safety in treating this condition. The record lists Merz Pharmaceuticals GmbH as sponsor.
The registry dates the study start to 2011-12 and primary completion to 2014-08; status is completed. An open-label extension is also described. In an open-label period, treatment is not masked in the way it is during a blinded comparison. The extension therefore has a different interpretive role from the randomized, placebo-controlled main period: its reported safety observations should not be read as a concurrent randomized comparison.
Important design details are not reported in the registry record, including the randomization sequence method, allocation concealment procedures, the duration of the main treatment period, the extension’s treatment schedule, and the precise masking arrangements for each study role. The record also does not report the protocol’s sample-size justification or enough information to reconstruct the conduct of every visit. Those absences limit detailed appraisal of design implementation, but do not change the stated randomized parallel-group design.
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.
Before assignment: A total of 290 subjects were enrolled in study. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. A total of 289 subjects were enrolled in main period. All of the 269 subjects who completed the main period of the study entered the open-label extension period.
Main Period
| Stage | IncobotulinumtoxinA (Xeomin) 400 Units | Placebo |
|---|---|---|
| STARTED | 144 | 145 |
| Treated | 144 | 145 |
| COMPLETED | 129 | 140 |
| NOT COMPLETED | 15 | 5 |
Reasons for not completing this period:
| Reason | IncobotulinumtoxinA (Xeomin) 400 Units | Placebo |
|---|---|---|
| Death | 0 | 1 |
| Adverse Event | 6 | 1 |
| Lack of Efficacy | 2 | 0 |
| Withdrawal by Subject | 5 | 2 |
| Predefined discontinuation criteria | 2 | 1 |
Open-Label Extension Period
| Stage | IncobotulinumtoxinA (Xeomin) 400 Units | Placebo |
|---|---|---|
| STARTED | 269 | 0 |
| Treated | 269 | 0 |
| COMPLETED | 218 | 0 |
| NOT COMPLETED | 51 | 0 |
Reasons for not completing this period:
| Reason | IncobotulinumtoxinA (Xeomin) 400 Units | Placebo |
|---|---|---|
| Adverse Event | 15 | 0 |
| Withdrawal by Subject | 14 | 0 |
| Lack of Efficacy | 5 | 0 |
| Death | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
| Non-compliance | 9 | 0 |
| Predefined discontinuation criteria | 6 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Safety Evaluation Set (SES) is the subset of all subjects who were exposed to Investigational product (IP) in the main period at least once.
| Characteristic | Unit | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | Main Period: Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 144 | 145 | 289 | |
| Age, Continuous | years | 57.3 (SD 11.2) | 57.0 (SD 13.0) | 57.2 (SD 12.1) |
| Gender: Female | Participants | 40 | 55 | 95 |
| Gender: Male | Participants | 104 | 90 | 194 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4, measured over Baseline and Week 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the Ashworth Scale for plantar flexors at Week 4. The record describes the scale as a measure of resistance to passive movement and a tool for categorizing spasticity severity. Its stated range is from 0, meaning no increase in tone, to 4, meaning the limb is rigid in flexion or extension. The outcome is expressed in units on the scale, and the registry identifies the summary measure as a mean with standard deviation.
As general context, a change score compares a participant’s follow-up measure with that participant’s baseline measure. Comparing group averages of change can describe whether the groups moved differently over the assessment period. The meaning of a scale change depends on the scale’s interpretation and on how the study collected and analyzed the ratings; the registry record does not define a threshold for a clinically important difference.
The endpoint focuses on plantar flexors and a specified follow-up visit, rather than all aspects of post-stroke spasticity. It was used as the primary efficacy measure in the registry record, but its numerical results, variability by arm, and between-group estimate are not reported in the registry record. The endpoint description alone therefore does not establish the direction, size, or precision of the observed treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial question and the planned primary outcome: change from baseline in plantar-flexor Ashworth Scale score at Week 4. It does not report numerical primary outcome results by arm or an estimated difference between the active-treatment and placebo groups. Consequently, the treatment contrast’s direction, magnitude, and precision are not reported in the registry record. No conclusion about the observed efficacy comparison can be drawn from the listed endpoint description alone.
The record identifies the outcome as a mean on a continuous scale and describes standard deviation as the dispersion measure. Standard deviation describes how spread out participant values are around a group mean; it is not itself an estimate of uncertainty in the difference between group means. A confidence interval, if reported, would express the range of effect estimates compatible with the data under the analysis assumptions. No confidence interval for the primary comparison is reported in the registry record.
The record names secondary outcomes concerning response at post-baseline visits and Ashworth Scale values at post-baseline visits. It also lists four outcome measures and five analyses. Those details indicate that the study record includes more than the single primary endpoint, but do not establish which analysis should be emphasized beyond the stated primary endpoint or how any multiple comparisons were handled. Numerical secondary-outcome results are not reported in the registry record.
The trial’s stated enrollment is 290, but an enrollment total cannot substitute for an outcome estimate. It does not show how many participants contributed data to the primary analysis in each group, how much outcome data were missing, or how precisely the treatment effect was estimated. The primary analysis population is defined as the Full Analysis Set, which included participants in the main-period Safety Evaluation Set with the primary efficacy variable available. Group-specific counts for that population are not reported in the registry record.
The registry record also contains safety counts for the main period and open-label extension. Those are descriptive participant counts, not evidence of the primary efficacy result. The extension is open-label and does not supply a concurrent placebo comparison in the figures listed. The reported safety information should therefore be interpreted separately from the missing numerical primary efficacy comparison.
Planning calculations based on an observed effect are illustrations of sample sizes that might be required under stated assumptions; they are not observed power and do not show that the study was adequately powered for its actual result. The trial’s sample-size justification and the numerical primary result are not reported in the registry record. The central statistical conclusion is therefore limited: the record describes a randomized test of a defined outcome, but does not provide the outcome data needed to quantify the comparison.
9. Statistical Methods Explained
Randomization is a design method intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics. In this trial, the registry identifies randomized allocation, a parallel model, and placebo control. These design features support a direct main-period comparison between incobotulinumtoxinA and placebo. General statistical context: randomization does not guarantee identical groups in a particular trial, and interpretation still depends on the analysis population, outcome data, and handling of missing observations. The record does not describe the randomization sequence or allocation concealment procedures.
Masking is intended to reduce the influence of treatment knowledge on participant experience, clinical care, outcome assessment, or analysis. The registry lists quadruple masking and the official title calls the study double-blind. The exact roles masked and how masking was maintained are not reported in the registry record. The open-label extension is distinct: open-label means treatment assignment is known rather than masked, so those observations should not be treated as an extension of the blinded placebo comparison without qualification.
The primary endpoint is a change score on the Ashworth Scale for plantar flexors at Week 4. The record states that the outcome is summarized as a mean and standard deviation. General statistical context: a mean is a measure of the center of a set of values, while a standard deviation describes their spread. Neither one alone gives the uncertainty of a between-group contrast. To assess uncertainty in that contrast, readers would generally look for an estimated difference with a confidence interval and an appropriate test result. Those numerical details are not reported in the registry record.
A confidence interval is a statistical range designed to express uncertainty around an estimate under a specified model and procedure. A narrower interval generally indicates greater precision than a wider interval, while the interval’s position relative to a null value helps assess which effects remain compatible with the data. This is general explanation, not a description of an analysis reported for this trial: the registry record does not provide a confidence interval for the primary endpoint, the model used to produce an estimate, or the hypothesis test result.
The Ashworth Scale is described as having five ordered levels, ranging from 0 to 4, with higher levels representing increasing resistance and the most severe stated category being rigidity in flexion or extension. Because the scale uses ordered categories, the statistical treatment of its scores can matter. A mean can summarize scores, as the registry record indicates, but the record does not explain the rationale for treating these ratings as a continuous measure or report sensitivity analyses using another approach. This does not establish that the chosen summary is inappropriate; it identifies information needed to evaluate the analysis fully.
Over-dispersion is a general issue in analyses of counts when observed variability exceeds what a model assumes. It can affect standard errors and confidence intervals if the model does not accommodate the extra variability. This concept is relevant to some types of count outcomes, but the primary endpoint is a scale change summarized by a mean and standard deviation. The registry record does not report a count model for the primary outcome, so over-dispersion should not be presumed to have been relevant to its primary analysis.
For safety outcomes, the record reports counts of participants affected and group sizes at risk, separately for serious and other adverse events. General statistical context: a count is descriptive, and a comparison of event proportions would need to account for the study design and any differences in follow-up or exposure. The listed safety counts do not by themselves provide adjusted estimates, confidence intervals, or tests. No such inferential safety analysis is reported in the registry record.
The record’s sample-size section is described as a planning illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. These are assumptions for a planning calculation, not proof that the trial was designed around that effect. General statistical context: sample-size planning asks how many participants may be needed to detect a prespecified effect under chosen assumptions. Retrospective calculations using an observed effect are especially dependent on that estimate and should not be called observed power. The trial’s original sample-size justification is not reported in the registry record.
Overall, the registry identifies the broad design and endpoint summary but omits the primary estimate, its uncertainty, and the detailed analysis procedure. Those omissions prevent independent reconstruction of the efficacy analysis and make the record insufficient for judging the statistical precision of the treatment contrast.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint at Week 4 and secondary outcomes that include response rates at post-baseline visits and Ashworth Scale values at post-baseline visits. It also reports four outcome measures and five analyses. Considering several outcomes, visits, or analyses creates a multiplicity question: when many comparisons are examined, the chance of at least one apparently notable result can increase. General statistical context: prespecified testing hierarchies or adjustment procedures can address this issue, but the appropriate method depends on the planned questions and analysis strategy.
The multiplicity strategy, any hierarchy among secondary outcomes, and any adjustment for repeated visits are not reported in the registry record. The numerical results for the primary and secondary outcomes are also not reported in the registry record, so their relationship and consistency cannot be assessed.
The primary population is defined as the Full Analysis Set: participants in the Safety Evaluation Set of the main period for whom the primary efficacy variable was available. The Safety Evaluation Set is described as participants exposed to investigational product at least once in the main period. The record does not report the exact number analyzed by arm, the number excluded from the Full Analysis Set, or reasons for unavailable primary measurements.
Missing-data handling, including any imputation, model-based approach, or sensitivity analysis, is not reported in the registry record. The record also does not state whether an intention-to-treat analysis was conducted or how deviations from assigned treatment were addressed. These details matter because excluding participants without an available outcome can affect the comparability created by randomization, depending on why values are missing. The available population definition helps identify who could enter the primary analysis, but does not explain how missing observations were handled.
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 |
|---|---|---|---|
| Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | 6 | 144 | 4.2% |
| Main Period: Placebo | 5 | 145 | 3.4% |
| Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units | 22 | 269 | 8.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | 13 of 144 |
| Main Period: Placebo | 13 of 145 |
| Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units | 31 of 269 |
Most frequent serious adverse event terms
| Event term | Organ system | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | Main Period: Placebo | Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units |
|---|---|---|---|---|
| Epilepsy | Nervous system disorders | 1 of 144 | 0 of 145 | 2 of 269 |
| Acute myocardial infarction | Cardiac disorders | 1 of 144 | 0 of 145 | 1 of 269 |
| Urinary tract infection | Infections and infestations | 0 of 144 | 1 of 145 | 1 of 269 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0 of 144 | 1 of 145 | 1 of 269 |
| Cerebrovascular accident | Nervous system disorders | 1 of 144 | 0 of 145 | 1 of 269 |
| Intracranial haematoma | Nervous system disorders | 0 of 144 | 1 of 145 | 0 of 269 |
| General physical health deterioration | General disorders | 1 of 144 | 0 of 145 | 0 of 269 |
| Jaundice cholestatic | Hepatobiliary disorders | 1 of 144 | 0 of 145 | 0 of 269 |
| Fall | Injury, poisoning and procedural complications | 1 of 144 | 0 of 145 | 0 of 269 |
| Fractured sacrum | Injury, poisoning and procedural complications | 1 of 144 | 0 of 145 | 0 of 269 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | Main Period: Placebo | Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units |
|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 7 of 144 | 7 of 145 | 10 of 269 |
| Fall | Injury, poisoning and procedural complications | 0 of 144 | 2 of 145 | 11 of 269 |
| Nasopharyngitis | Infections and infestations | 3 of 144 | 1 of 145 | 4 of 269 |
| γ-glutamyltransferase increased | Investigations | 0 of 144 | 0 of 145 | 7 of 269 |
| Headache | Nervous system disorders | 1 of 144 | 3 of 145 | 2 of 269 |
| Oedema peripheral | General disorders | 0 of 144 | 3 of 145 | 3 of 269 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 144 | 0 of 145 | 6 of 269 |
| Vision blurred | Eye disorders | 3 of 144 | 0 of 145 | 1 of 269 |
Serious events with the highest arm-level rate: epilepsy (0.7%), acute myocardial infarction (0.7%), general physical health deterioration (0.7%), jaundice cholestatic (0.7%), fall (0.7%).
For the main period, the registry reports serious adverse events in 6 of 144 participants in the incobotulinumtoxinA group and 5 of 145 participants in the placebo group. Other adverse events are reported for 13 of 144 participants in the active-treatment group and 13 of 145 participants in the placebo group. These are participant counts and denominators, not estimates of a causal treatment effect.
For the open-label extension, 22 of 269 participants are reported with serious adverse events, and 31 of 269 with other adverse events. Because this period is open-label and has no concurrent placebo group in the listed figures, its counts should not be interpreted as a randomized comparison with the main-period placebo arm. Follow-up and exposure details needed to compare event rates are not reported in the registry record.
The listed serious-event terms include epilepsy, acute myocardial infarction, general physical health deterioration, jaundice cholestatic, fall, and fractured sacrum, each reported at 0.7%. The record does not establish from these listings whether events were caused by treatment. Death counts are not reported in the registry record. The figures are best read as a description of reported events in the stated groups and periods, without inferring a treatment effect or absence of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, placebo-controlled trial was conducted to investigate incobotulinumtoxinA for lower-limb spasticity after stroke. It specifies the primary endpoint as change from baseline in plantar-flexor Ashworth Scale score at Week 4 and describes the scale’s interpretation and the primary analysis population.
However, the registry record does not report the numerical outcome by group, the estimated treatment difference, or an interval expressing uncertainty. It therefore does not show whether the groups differed on the primary endpoint, how large any observed difference was, or how precisely it was estimated. The endpoint name and study purpose are not substitutes for results.
The safety counts describe participants reported with serious and other adverse events during the main period and open-label extension. They do not, on their own, identify causes or establish that the treatments differ in safety. The extension figures also come from an open-label period rather than the randomized placebo comparison.
General statistical context: a trial result is most informative when the estimate is interpreted alongside its uncertainty, the population analyzed, the amount of missing data, and the analysis plan. The registry record does not report several of those elements. It also does not provide a sample-size justification or detailed multiplicity and missing-data methods. Those gaps limit what can be concluded from this record, even though the design and primary question are clearly described.
Accordingly, the record supports a description of what the investigators set out to compare, but not a numerical judgment about the observed efficacy contrast. It should not be read as evidence either for or against a treatment effect. Further outcome reporting would be needed to assess the magnitude, direction, and precision of the primary comparison.
13. Why This Trial Matters Statistically
This study illustrates why a clearly stated primary endpoint and numerical results are both necessary for statistical interpretation. The registry identifies a specific scale, muscle group, follow-up visit, and analysis population. Those details define the target comparison more clearly than a broad question about spasticity alone. Yet without group summaries and a treatment-effect estimate, the reader cannot quantify the primary finding.
The design also highlights the distinction between a randomized, masked main period and an open-label extension. Randomized placebo comparisons can support a more direct assessment of between-group differences, while descriptive observations from an open-label period answer a different kind of question. Combining the periods without accounting for that distinction could obscure what the data can establish.
There are several outcomes and analyses listed in the record. That makes prespecification and multiplicity handling relevant to interpretation, especially when outcomes are assessed at multiple visits. The registry record does not report how those issues were addressed. Similarly, the primary analysis population is defined, but the number included by arm and the handling of missing observations are not reported.
Finally, planning illustrations based on an observed effect should be separated from the original design rationale and from the observed evidential strength of a result. They do not establish observed power. This trial is therefore a useful example of how design metadata can clarify the intended question while incomplete outcome reporting still prevents an assessment of effect size and precision.
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 most consequential limitation for interpreting the efficacy question is that numerical primary outcome results are not reported in the registry record. The record does not provide group-specific means, standard deviations, the treatment contrast, a confidence interval, or a test result. The primary endpoint’s direction, magnitude, and precision therefore cannot be assessed from this record.
The record defines the Full Analysis Set in relation to exposure and availability of the primary efficacy variable, but does not report the number analyzed in each group or the amount and pattern of missing outcome data. Missing-data methods and sensitivity analyses are not reported in the registry record. Without these details, the impact of incomplete measurements on the primary comparison cannot be evaluated.
The registry lists several outcome measures and analyses, including secondary outcomes across post-baseline visits, but does not report a multiplicity plan. It also does not report the statistical model, the method used to compare groups, or whether adjusted analyses were conducted. These omissions constrain independent appraisal of the inferential approach.
The sample-size justification, randomization sequence method, allocation concealment procedures, and detailed masking procedures are not reported in the registry record. The record identifies a quadruple-masked randomized design, but does not clarify which roles were masked. Safety information includes participant counts and selected serious-event terms, but attribution, detailed exposure information, and comparative inferential estimates are not reported. Death counts are not reported in the registry record.
These limitations concern what can be established from the registry record; they should not be mistaken for proof that the trial lacked the procedures or analyses in question. The record is sufficient to identify the trial’s stated design and question, but not to reconstruct its full statistical analysis or evaluate the numerical efficacy result.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke — NCT01464307.
- Registry record last updated 2016-11-07; status last verified 2016-09.
- Results first posted 2016-11-07.
- 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
NCT01464307 is a completed Phase 3 randomized, quadruple-masked, parallel-group study sponsored by Merz Pharmaceuticals GmbH. The record lists enrollment of 290, a start date of 2011-12, and primary completion in 2014-08. The study compared incobotulinumtoxinA (Xeomin) 400 Units with placebo for post-stroke spasticity of the lower limb and included an open-label extension.
The primary endpoint was change from baseline in the Ashworth Scale for plantar flexors at Week 4. The scale ranges from 0 to 4, and the stated summary measure is a mean with standard deviation. The primary analysis population was the Full Analysis Set, defined using exposure during the main period and availability of the primary efficacy variable.
The registry record does not report numerical primary efficacy results, the treatment-effect estimate, or its precision. It includes descriptive safety counts for the main period and extension, but those counts do not establish causation or an efficacy comparison.