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 Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke (NCT00142792), a randomized na study. The primary outcome is Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00142792 |
| Phase | NA |
| Condition | Stroke, Acute, Stroke, Hemiparesis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 122 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MetroHealth Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns people with acute stroke, stroke, or hemiparesis. It reports enrollment of 122 participants and describes the primary analysis population as all cases, intent-to-treat, adjusted for site. Further eligibility details, including age requirements and the degree or duration of impairment required for entry, are not reported in the registry record.
Intervention
The study used a neuromuscular electrical stimulation device with cyclic and EMG-triggered capabilities. The cyclic-stimulation group received repeated automatic hand opening and closing without requiring voluntary effort. The EMG-triggered group attempted wrist and finger extension in response to a cue and received stimulation after reaching a preset muscle-activity threshold. Treatment schedule and duration are not reported in the registry record.
Comparator
The third group received sensory-only stimulation: cyclic stimulation at an intensity intended to be felt without causing muscle contraction. This makes the comparison one among three stimulation approaches, including a sensory-only condition. The registry record does not report a no-stimulation or usual-care group, nor does it give a detailed account of other care received by participants.
Primary question
The primary outcome was the Fugl-Meyer Motor Assessment, a measure of motor impairment. The central question is whether outcome scores across the study’s assessment occasions differed among the cyclic, EMG-triggered, and sensory-stimulation groups. The registry record specifies the outcome and an adjusted analysis population, but numerical group estimates and statistical comparisons are not reported in the registry record.
3. Trial Design
This was a randomized, single-masked, parallel-group study with enrollment of 122. Its status is completed, and the listed phase is not applicable. MetroHealth Medical Center is identified as the sponsor. The recorded start is 2005-12 and primary completion is 2010-03. The identity of the people who were masked, the allocation ratio, and the randomization procedure are not reported in the registry record.
Three stimulation approaches are described. Cyclic stimulation automatically repeated finger and thumb flexor and extensor stimulation to open and close the hand; participants were instructed to relax and not assist. Sensory stimulation was cyclic but set at a level that could be felt without producing muscle contraction. In the EMG-triggered group, participants attempted to extend the affected wrist and fingers after an audio cue, with stimulation delivered after their muscle activity reached a preset threshold. Each approach used an NMES device, with the record specifically describing the device’s cyclic and EMG-triggered capabilities.
The Fugl-Meyer Motor Assessment was scheduled at baseline, mid-treatment, end of treatment, and follow-up at 1-, 3-, and 6-months post-treatment. The primary population is described as all cases, intent-to-treat, with adjustment for site. The record also lists the Arm Motor Ability Test as a secondary outcome, focused on activity limitation in the hemiparetic arm. Details about treatment duration, visit windows, adherence, and the care received outside the stimulation intervention are not reported in the registry record.
The registry record lists 2 outcome measures and 4 analyses, but does not describe the allocation concealment, masking procedures, or analysis methods for each outcome and occasion. It also does not report a planned sample-size target or the rationale for enrollment. Those details should not be inferred from the completed enrollment or from planning illustrations based on observed effects.
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 | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim |
|---|---|---|---|
| STARTED | 39 | 41 | 42 |
| Completed Intervention | 35 | 37 | 37 |
| COMPLETED | 27 | 26 | 30 |
| NOT COMPLETED | 12 | 15 | 12 |
Reasons for not completing this period:
| Reason | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim |
|---|---|---|---|
| Death | 0 | 0 | 1 |
| Withdrawal by Subject | 3 | 2 | 3 |
| Lost to Follow-up | 8 | 11 | 7 |
| No category | 1 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: All cases, intent-to-treat, adjusted for site
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: Non-hospitalized adults within 6 months of stroke aged 21-89 years.
| Characteristic | Unit | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim | Total |
|---|---|---|---|---|---|
| Participants analysed | 39 | 41 | 42 | 122 | |
| Age, Continuous | years | 55.0 (47.4 to 65.9) | 58.6 (48.9 to 67.5) | 55.8 (47.6 to 66.7) | 55.1 (47.6 to 67.1) |
| Sex: Female, Male: Female | Participants | 18 | 17 | 16 | 51 |
| Sex: Female, Male: Male | Participants | 21 | 24 | 26 | 71 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 38 | 40 | 41 | 119 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 2 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 14 | 9 | 32 |
| Race (NIH/OMB): White | Participants | 30 | 27 | 30 | 87 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 39 | 41 | 42 | 122 |
| Months from Stroke | months | 2.0 (1.3 to 4.2) | 2.9 (1.5 to 4.7) | 3.2 (1.7 to 5.0) | 2.8 (1.5 to 4.5) |
6. Primary Endpoint
The registry lists the primary outcome as Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure, measured over FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment..
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Fugl-Meyer Motor Assessment (FMA), described as a measure of motor impairment after stroke. The record says the battery covers six dimensions, including upper- and lower-limb motor impairment, range of motion, pain, reflexes, and sensation. Each of 33 items is graded on a 3-point ordinal scale: 0 for cannot perform, 1 for perform partially, and 2 for perform fully. Item scores are summed to give a score ranging from 0 to 66, with higher scores indicating better motor function. The assessment was administered with the participant seated.
The FMA is relevant to the trial question because the interventions were intended to address upper-limb recovery, while the endpoint quantifies motor impairment using a defined assessment. It is not itself a direct measure of every aspect of daily activity. The registry separately lists the Arm Motor Ability Test as a secondary measure of activity limitation in the hemiparetic arm. Considering both constructs can distinguish measured motor impairment from activity-related limitations, although the registry record does not report numerical findings for either outcome.
The FMA was scheduled at six occasions: baseline, mid-treatment, end of treatment, and follow-up at 1-, 3-, and 6-months post-treatment. The primary outcome parameter is a least-squares mean with a 95% confidence interval. The registry record does not report those means, intervals, or the comparisons among the groups, so the outcome definition alone does not indicate the direction or size of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of three electrical-stimulation approaches and identifies the FMA as the primary outcome. It does not report FMA estimates, confidence intervals, p-values, or numerical comparisons among groups. Consequently, the record does not establish from the posted results whether scores changed over time, whether the groups differed, or how precise any such difference might be. The outcome schedule and analysis description are not substitutes for the missing numerical results.
The primary outcome is a continuous score, and the record specifies least-squares means with 95% confidence intervals. In general, a least-squares mean is an estimate adjusted for terms included in an analysis model; the record identifies adjustment for site in the primary analysis population. The specific model, additional covariates, and contrasts are not reported in the registry record. A confidence interval communicates uncertainty around an estimate under the analysis assumptions. Without the interval endpoints and the associated estimate, the precision of the primary outcome cannot be assessed.
The trial enrolled 122 participants. The adverse-event record lists 39 at risk in the cyclic-stimulation group, 41 in the EMG-triggered group, and 42 in the sensory-stimulation group. Serious adverse events were recorded for 10, 13, and 9 participants, respectively; other adverse events were recorded for 1, 3, and 2 participants, respectively. These are counts, not a complete account of event severity, timing, relatedness, or clinical consequences. Deaths are not reported in the registry record. The listed at-risk counts do not by themselves explain follow-up completeness or how missing safety observations were handled.
The registry lists serious-event terms with percentages: Illness, +/- hospitalization, 17.1%; Other, 14.6%; Surgery or procedure, 9.8%; Fall, 5.1%; and Seizure, 4.9%. The record does not specify the denominator or explain whether people could contribute to more than one term. These percentages therefore should not be read as directly comparable group-specific risks.
Overall, the registry record supports a description of the trial structure, outcome definitions, and recorded adverse-event counts. It does not provide the primary efficacy estimates needed to quantify the observed outcome pattern or its uncertainty. No treatment conclusion follows from the design description or adverse-event counts alone.
9. Statistical Methods Explained
The primary outcome is continuous: the FMA produces a summed score, and the registered summary parameter is a least-squares mean. In general, a mean describes the central level of a quantitative outcome, while a least-squares mean is model-based and can account for specified features of the analysis. The registry identifies adjustment for site, but the exact model formula and any further adjustments are not reported in the registry record. It is therefore possible to describe the planned summary type, but not to reconstruct the analysis or verify which model assumptions were used.
What does a confidence interval express?
The FMA outcome is paired with a 95% confidence interval. In general, a confidence interval gives a range of estimates compatible with the observed data and the assumptions of the statistical procedure. A narrower interval indicates greater precision than a wider interval, but neither width nor location can be assessed without its endpoints. The registry record does not report the primary least-squares means or their intervals. Thus, the posted outcome definition cannot show how precisely a group mean or a difference between groups was estimated.
A confidence interval for a group mean is not automatically an interval for a treatment contrast. To interpret a comparison, readers need the estimated contrast and its uncertainty, or another clearly specified comparison. Those results are not reported in the registry record. The record also does not identify the exact contrasts among the three groups or specify whether the primary comparison was between groups at a particular occasion, a change from baseline, or another summary across occasions.
Why do repeated assessments matter?
The FMA was planned at baseline, mid-treatment, end of treatment, and follow-up at 1-, 3-, and 6-months post-treatment. Repeated measurements can describe the course of an outcome rather than a single endpoint. General statistical methods for repeated observations need to account for the fact that measurements from one participant are related; treating each observation as independent can misstate uncertainty. The record does not report the method used to account for within-participant correlation, nor does it say which occasion or time contrast drove each of the listed analyses.
The FMA is built from ordinal item ratings that are summed into a score. The registered analysis treats the outcome as continuous, with a least-squares mean. That summary can be useful for describing average scores, but it does not show the distribution of individual item responses or how participants’ scores varied. The record does not report additional distributional summaries or diagnostic checks. General model-based interpretations depend on how well the analysis assumptions fit the data; those checks cannot be assessed from the outcome description alone.
What does adjustment for site mean?
The primary population is described as all cases, intent-to-treat, adjusted for site. In general, an intent-to-treat approach aims to analyze participants in their assigned groups, regardless of adherence or treatment received. Site adjustment accounts for site in the analysis model, which may be relevant when outcomes vary across study locations. The registry record does not identify the number of sites, the randomization blocks or strata, or how participants with missing observations were treated. The phrase intent-to-treat does not, by itself, specify a missing-data method or prove that every enrolled participant contributed every scheduled outcome.
How should planning illustrations be read?
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations consider an effect to detect expressed as a stated fraction of the observed effect. These are scenario-based planning calculations, not evidence that the trial had a particular probability of detecting an effect and not a description of the trial’s original design. The record does not report the trial’s own sample-size justification. The planning estimates themselves are not reported in the registry record.
In general, a planning calculation estimates the sample size associated with chosen assumptions about an effect and a statistical procedure. Changing the assumed effect or other design choices changes the planning result. An effect estimated from trial data is uncertain, so a calculation anchored to that estimate is not a substitute for a prospective design justification. No sample-size illustration should be interpreted as observed power, and no such calculation fills the gap left by unreported primary outcome estimates.
Why can excess variability matter?
General count-data methods sometimes need to account for over-dispersion, which occurs when variation is greater than a chosen model expects. This can affect uncertainty estimates and conclusions drawn from count outcomes. The primary endpoint in this trial is a continuous FMA score, not a count of events, so this concept should not be used to infer a method applied to the primary analysis. The registry record does not report a model for adverse-event counts or any over-dispersion assessment.
Finally, the record lists 4 analyses but does not describe their specific hypotheses, estimands, or statistical procedures. The existence of repeated time points and more than one outcome makes clear reporting of each analysis important, but the exact analytic choices cannot be recovered from the count of analyses alone. No unreported tests, adjustments, interim analyses, or model details can be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The study includes a primary FMA outcome measured on six occasions, a secondary activity-limitation outcome, and 4 listed analyses. When a study evaluates multiple outcomes, time points, or contrasts, general statistical interpretation must consider multiplicity: the more questions examined, the greater the opportunity for apparently notable findings by chance if no adjustment or hierarchy is specified. The registry record does not report a multiplicity strategy, a hierarchy among time points, or which contrasts were designated as primary. It also does not report interim analyses or stopping rules.
The registered primary analysis population is described as all cases, intent-to-treat, adjusted for site. That statement identifies an intended analysis population and a site adjustment, but it does not explain the handling of missing outcome measurements. The FMA was scheduled at baseline, mid-treatment, end of treatment, and follow-up at 1-, 3-, and 6-months post-treatment; completeness at those occasions and reasons for missingness are not reported in the registry record. The method used to address missing data, if any, is also not reported in the registry record.
Participant flow, withdrawals, treatment adherence, and the number contributing to each outcome analysis are not reported in the registry record. Without those details, the phrase intent-to-treat cannot establish how the analysis population was implemented in practice. The record also does not describe sensitivity analyses for missing outcomes or deviations from assigned treatment. These omissions limit assessment of how robust the findings would be to incomplete follow-up, even if numerical outcome estimates were available.
The sample-size assumptions describe planning illustrations rather than the trial’s own design justification. The record does not report a prospective sample-size rationale or explain how multiplicity and missing observations were handled in planning. These are distinct issues: a planning illustration does not document the protocol’s intended analysis, and an intent-to-treat label does not resolve missing-data or multiplicity questions.
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 |
|---|---|---|---|
| A. Cyclic Stim | 10 | 39 | 25.6% |
| C. EMG-Triggered | 13 | 41 | 31.7% |
| B. Sensory Stim | 9 | 42 | 21.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| A. Cyclic Stim | 1 of 39 |
| C. EMG-Triggered | 3 of 41 |
| B. Sensory Stim | 2 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim |
|---|---|---|---|---|
| Illness, +/- hospitalization | General disorders | 5 of 39 | 7 of 41 | 5 of 42 |
| Other | General disorders | 4 of 39 | 6 of 41 | 2 of 42 |
| Surgery or procedure | Investigations | 1 of 39 | 4 of 41 | 0 of 42 |
| Fall | General disorders | 2 of 39 | 0 of 41 | 1 of 42 |
| Seizure | Nervous system disorders | 0 of 39 | 2 of 41 | 1 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim |
|---|---|---|---|---|
| Shock | Injury, poisoning and procedural complications | 0 of 39 | 3 of 41 | 2 of 42 |
| Muscle Twitch | Nervous system disorders | 1 of 39 | 0 of 41 | 0 of 42 |
Serious events with the highest arm-level rate: illness, +/- hospitalization (17.1%), other (14.6%), surgery or procedure (9.8%), fall (5.1%), seizure (4.9%).
The safety record gives, for each group, the number at risk and the number of participants recorded with serious and other adverse events. For cyclic stimulation, 39 participants were at risk, 10 had a serious adverse event, and 1 had another adverse event. For EMG-triggered stimulation, 41 were at risk, 13 had a serious adverse event, and 3 had another adverse event. For sensory stimulation, 42 were at risk, 9 had a serious adverse event, and 2 had another adverse event. These are posted counts and should not be converted into additional rates or comparisons without information about observation time and the registry’s event-counting rules.
The record lists serious-event terms and percentages: Illness, +/- hospitalization, 17.1%; Other, 14.6%; Surgery or procedure, 9.8%; Fall, 5.1%; and Seizure, 4.9%. It does not report the denominator for those percentages, whether terms could overlap for one participant, event timing, or whether events were judged related to stimulation. The criteria used to classify seriousness are not reported in the registry record. Deaths are not reported in the registry record.
In general, adverse-event counts describe recorded events or affected participants under a study’s reporting rules; they do not alone establish cause. The posted group counts should be read as safety descriptions, not as proof for or against a causal difference among the stimulation approaches.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed randomized study compared cyclic, sensory-only, and EMG-triggered electrical stimulation in people described by the conditions stroke, acute stroke, and hemiparesis. It identifies the FMA as the primary motor-impairment outcome and the Arm Motor Ability Test as a secondary activity-limitation outcome. It also specifies repeated assessment occasions and an analysis population described as all cases, intent-to-treat, adjusted for site.
Those details describe the question and the measurement plan, but they do not report the primary outcome results. The record does not provide group means, changes, contrasts, confidence intervals, or p-values for the FMA. It therefore cannot show the size, direction, or precision of an observed difference among groups. The outcome schedule also means that a single unreported result would not be enough to describe the complete time course; the relevant occasion and contrast would need to be specified.
The adverse-event figures document recorded serious and other adverse events among the stated at-risk participants. They do not provide enough information to determine causality, compare event rates over equivalent follow-up, or characterize the full clinical context. The listed serious-event percentages lack a reported denominator and may not correspond to mutually exclusive participants. Deaths are not reported in the registry record.
In general, a randomized design can support comparisons when allocation, follow-up, measurement, and analysis are adequately implemented and transparently reported. The registry identifies randomization but does not provide enough detail to assess every aspect of implementation or analysis. The record also does not report the protocol’s sample-size rationale, missing-data approach, or multiplicity plan. These limitations do not imply a particular outcome; they define what can and cannot be concluded from the recorded information.
Accordingly, the available record supports a description of trial design, outcome definitions, timing, and safety counts. It does not support a conclusion about whether any stimulation approach produced a greater FMA result, whether any difference was clinically important, or whether one approach had a different safety profile.
13. Why This Trial Matters Statistically
This trial is statistically notable for the structure of its measurement plan. The FMA was scheduled repeatedly from baseline through follow-up at 1-, 3-, and 6-months post-treatment. Such repeated measurements can distinguish a result at the end of treatment from a pattern over follow-up, but they also require clear definition of the target comparison and an analysis that respects within-participant dependence. The registry record supplies the assessment schedule but not the model or time-specific estimates needed to evaluate that pattern.
The study also distinguishes motor impairment from activity limitation. The FMA is the primary measure of motor impairment, while the Arm Motor Ability Test is listed for activity limitation in the hemiparetic arm. These outcomes address related but different aspects of recovery. Reporting both can help clarify what a measured score represents; however, the registry record does not include numerical results for either measure.
Three groups make the comparison more informative than a simple two-condition description, but they also create a need to specify which group contrasts answer the primary question and how multiple comparisons are handled. The registry lists 4 analyses without identifying their hypotheses or procedures. The randomization, parallel design, and site-adjusted intent-to-treat population are useful design descriptors, yet they do not by themselves resolve questions about missing data, masking, or the exact estimand.
The safety record adds another dimension by giving group-specific counts of participants at risk and affected. Those counts are meaningful descriptive information, while their interpretation depends on event definitions, follow-up, and reporting denominators. Together, the record illustrates why transparent numerical outcome estimates and analysis details are essential: a well-defined endpoint and a randomized design cannot replace the estimates and uncertainty needed to interpret the observed data.
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 principal limitation of the registry record for statistical interpretation is that it does not report numerical results for the primary FMA outcome. Least-squares means, 95% confidence intervals, comparisons among the groups, and p-values are not reported in the registry record. Numerical results for the secondary Arm Motor Ability Test are also not reported. The effectiveness and precision of the interventions therefore cannot be evaluated from these details.
The analysis description is incomplete. Although the primary population is stated as all cases, intent-to-treat, adjusted for site, the specific model, included covariates, planned contrasts, and handling of repeated measurements are not reported. The record lists 4 analyses but does not describe their individual purposes. A multiplicity procedure, interim analyses, and the prospective sample-size justification are not reported in the registry record.
Information needed to assess follow-up and implementation is also absent. The record does not report participant flow by group, outcome completeness at each occasion, withdrawal reasons, adherence, or how missing data were handled. It identifies the study as single-masked, but who was masked and how masking was maintained are not reported. Allocation concealment and the randomization procedure are not described.
The safety counts have limited context: the record does not state the event-counting rules, duration of safety observation, relatedness assessments, or the denominator behind the serious-event term percentages. Deaths are not reported in the registry record. These gaps limit interpretation of safety patterns and prevent a full assessment of comparability across groups. They are reporting limitations, not evidence of a particular benefit or harm.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke — NCT00142792.
- Registry record last updated 2018-03-29; status last verified 2018-03.
- Results first posted 2018-03-29.
- 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
NCT00142792, titled Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke, is recorded as a completed, randomized, single-masked, parallel-group study sponsored by MetroHealth Medical Center. Enrollment was 122. The listed start is 2005-12 and primary completion is 2010-03. The registry record describes cyclic stimulation, sensory-only stimulation, and EMG-triggered stimulation.
The primary outcome is the Fugl-Meyer Motor Assessment, a motor-impairment measure with scores ranging from 0 to 66 and higher scores indicating better motor function. It was scheduled at baseline, mid-treatment, end of treatment, and follow-up at 1-, 3-, and 6-months post-treatment. The Arm Motor Ability Test is listed as a secondary outcome. Primary numerical results and analysis details beyond an intent-to-treat population adjusted for site are not reported in the registry record.
Safety counts are listed for serious and other adverse events by group. The record does not report deaths, the denominator for serious-event term percentages, or details needed to determine event relatedness. The registry supports description of the design and reported measures, but not a numerical assessment of the primary outcome differences.