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 Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery (NCT01220739), a randomized phase 2 study. The primary outcome is Symptomatic Intracranial Hemorrhages.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01220739 |
| Phase | Phase 2 |
| Condition | Ischemic Stroke |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 12 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of California, San Diego |
| Results posted | Yes |
2. Clinical Question
Population
People with acute ischemic stroke treated with IV tPA. The registry describes IV tPA treatment as beginning within 3 hours of symptom onset; it does not report further details about the participants in the primary endpoint population.
Intervention
Transcranial laser therapy with the NeuroThera® Laser System, given after IV tPA. The arm description places treatment no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Comparator
Sham transcranial laser therapy after IV tPA. The sham procedure is described as occurring within the same timing window as active laser therapy.
Primary question
How many participants experienced symptomatic intracranial hemorrhage within 36 hours from tPA initiation in each arm?
The clinical question is primarily about safety. Both groups received IV tPA, while the randomized difference was whether the subsequent transcranial laser procedure was active or sham. This comparison is intended to distinguish outcomes associated with adding active laser treatment from outcomes occurring under the sham procedure, against a shared background of IV tPA treatment.
The registry also describes the study as assessing preliminary efficacy. However, the posted primary endpoint is a count of participants with symptomatic intracranial hemorrhages, and the record does not post an efficacy result that permits a treatment-effect assessment. The registry lists no estimable two-arm comparison for the binary primary endpoint.
The brief summary says the start of the laser procedure needed to be feasible within 6 hours of stroke onset. The arm descriptions instead place the procedure no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset. The registry record does not explain how these timing statements relate to one another.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group Phase 2 trial. The registry reports enrollment of 12 and a status of terminated. The sponsor was the University of California, San Diego. The recorded start was 2011-06, and primary completion was 2012-12. The reason for termination is not reported in the registry record.
Participants were assigned to IV tPA followed by sham transcranial laser therapy or IV tPA followed by active transcranial laser therapy. The arm descriptions say IV tPA was to begin within 3 hours of stroke symptom onset. They describe the laser procedure as occurring no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset. The intervention is identified as a device, the NeuroThera® Laser System, described as providing noninvasive transcranial laser therapy with invisible infrared light.
The primary outcome is symptomatic intracranial hemorrhages, measured as the number of participants with the event within 36 hours from tPA initiation. The posted arm results record 0.0 participants with the event for sham transcranial laser therapy and 0.0 for transcranial laser therapy. The registry does not provide an estimable comparison of these binary results.
For the primary endpoint, the registry lists 7 participants in the sham arm and 5 in the active-therapy arm. These arm counts describe the posted outcome record; they do not establish how missing observations, exclusions, or analysis populations were handled. Those details are not reported in the registry record. Nor does the record explain the termination or provide a narrative of trial conduct beyond the design and outcome information.
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 | Sham Transcranial Laser Therapy | Transcranial Laser Therapy |
|---|---|---|
| STARTED | 7 | 5 |
| COMPLETED | 7 | 5 |
| NOT COMPLETED | 0 | 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 | Sham Transcranial Laser Therapy | Transcranial Laser Therapy | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 5 | 12 | |
| Age, Continuous | years | 64.1 (SD 8.5) | 66.8 (SD 12.7) | 65.2 (SD 10.0) |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 7 |
| Randomization NIH Stroke Scale | score on a scale | 12.3 (SD 3.2) | 15.0 (SD 2.4) | 13.4 (SD 3.1) |
| Post-tPA Baseline/Treatment NIH Stroke Scale | score on a scale | 8.7 (SD 5.4) | 9.6 (SD 5.4) | 9.1 (SD 5.2) |
6. Primary Endpoint
The registry lists the primary outcome as Symptomatic Intracranial Hemorrhages, measured over 36 hours from tPA initiation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with symptomatic intracranial hemorrhages within 36 hours from tPA initiation. It is a binary outcome at the participant level: each participant either meets the endpoint definition or does not. The registry gives the unit as participants and the parameter as a number, rather than a rate or time-to-event measure. It does not add a detailed clinical definition of symptomatic hemorrhage or describe how events were assessed.
As a general matter, symptomatic intracranial hemorrhage is used as a safety outcome in acute stroke treatment research because bleeding in the brain accompanied by symptoms is a serious event relevant to treatment safety. A prespecified observation window makes the outcome’s timing explicit: the count applies to events within the stated period after tPA initiation, not to events at any later time. The registry record does not explain why this specific window or endpoint was selected for this trial.
The posted results record no events in either arm: 0.0 participants for sham therapy and 0.0 for active therapy. That is a descriptive count, not a precise estimate of the underlying risk. With no events recorded in either group, the registry does not report an estimable comparison for the two-arm binary endpoint. The result therefore cannot establish that the groups have the same risk, nor does it quantify how much uncertainty remains about possible differences.
The endpoint is focused on one safety outcome. It does not, by itself, summarize overall safety, recovery, or functional benefit. The record lists other adverse-event information separately, and those figures should not be treated as interchangeable with the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint results are 0.0 participants with symptomatic intracranial hemorrhages in the sham transcranial laser therapy arm and 0.0 in the transcranial laser therapy arm, within 36 hours from tPA initiation. The registry’s comparison status says values are missing or not estimable for a two-arm comparison of this binary endpoint. Accordingly, the posted result supports a description of the recorded counts, but not a comparative effect estimate.
That distinction matters. An observed count of zero is not a demonstration that the true probability of an event is zero. In a trial with limited enrollment, an event can be absent in the observed participants while remaining possible in a broader population. A confidence interval, when available, describes uncertainty around an estimate; no confidence interval is reported for this endpoint. Without an estimable comparison, the registry does not quantify how compatible the results are with differing event risks between arms.
The arm counts are 7 for sham therapy and 5 for active therapy. These are small groups, and the absence of an observed primary event leaves little information for judging comparative safety on this outcome. The registry lists no analysis result, p-value, or adjusted estimate for the primary endpoint. It would not be appropriate to infer statistical equivalence, equivalence of safety, or evidence of no difference from the two zero counts.
The record’s study purpose included safety and preliminary efficacy, but the primary result is a safety count. No efficacy analysis is posted in the registry record. Consequently, the primary endpoint cannot answer whether active laser therapy changed recovery or any other efficacy outcome.
Serious adverse events are reported separately: 3 participants in the sham arm and 2 in the active arm were affected. Other adverse events are reported for 6 participants in the sham arm and 5 in the active arm. These figures are counts, not a comparative analysis, and the registry does not provide adjusted estimates or uncertainty intervals for them. The listed serious-event terms and percentages also require care: the record does not specify their arm assignment in the available information.
The trial status is terminated, but the reason is not reported in the registry record. Termination alone does not establish that safety concerns, efficacy findings, recruitment, or another factor caused the trial to stop. Without that context and without comparative analyses, interpretation should remain limited to the posted descriptive findings.
9. Statistical Methods Explained
The statistical information in the registry is limited. The study is described as randomized and parallel-group, but the registry record does not report the method used to generate the random allocation sequence, how allocation was concealed, or how masking was maintained. The masking designation is quadruple, but the identities of the masked groups are not specified in the posted information. These details can affect the risk of bias and the interpretation of a trial, but they should not be inferred from the design labels alone.
What does a binary outcome mean?
A binary endpoint classifies each participant according to whether an event occurred. For this trial, the event is symptomatic intracranial hemorrhage within the stated follow-up window. The registry reports the number of participants with the event in each arm, rather than a continuous measurement or a time-to-event estimate. Counts can be useful for describing what happened among enrolled participants, but a comparative analysis generally also needs a method for quantifying uncertainty around the difference between groups.
The posted counts are zero in both arms. For a two-arm binary comparison, an observed event difference cannot be estimated from two arms with no observed events in the way that a comparison with events in at least one arm can be. The registry explicitly marks the comparison values as missing or not estimable. It reports no test statistic, p-value, confidence interval, or adjusted result. The absence of those estimates is not evidence that the groups are equivalent; it means the registry does not provide a quantified comparison for this endpoint.
What can a confidence interval contribute?
In general, a confidence interval expresses the precision of an estimate by giving a range of values compatible with the data under the method’s assumptions. A narrow interval indicates greater precision than a wide interval, while an interval spanning values that represent different conclusions can signal substantial uncertainty. No confidence interval for the primary comparison is reported in the registry record. Therefore, readers cannot use the posted results to see a numerical range for plausible differences in event occurrence.
Why do small groups matter?
When groups contain few participants, each observed event can have a large influence on a summary, and no observed events can leave substantial uncertainty about the frequency of an uncommon outcome. This is a general statistical limitation, not a claim about what would have happened to particular participants. The recorded arm sizes are 7 and 5. The registry does not report a sample-size justification, a target effect, or a planned precision for the primary endpoint, so it is not possible to determine from the record whether the study was designed to estimate a clinically important difference with a specified degree of precision.
What do the planning assumptions mean?
The registry 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. It says the effect to detect is a stated fraction of the observed effect. Such calculations are illustrations of sample sizes under stated assumptions; they are not observed power and do not establish the power of the trial as conducted. The registry record does not report the trial’s own design rationale or a sample-size justification. Since the primary binary comparison is marked not estimable, the posted record does not support treating an illustration based on an observed effect as evidence of the study’s ability to detect a particular effect.
More generally, a planning calculation depends on the assumed outcome frequency, target effect, error rate, allocation, and statistical method. Changing assumptions changes the calculated requirement. These are design-stage considerations; they do not transform a small observed trial into a more precise result, and they do not replace a reported analysis. No additional planning assumptions beyond those stated in the registry record should be attributed to this study.
Why might event counts be sparse?
For binary safety outcomes, sparse data occur when very few participants experience the event, especially when no events are recorded in one or both arms. Some standard methods rely on approximations that can behave poorly with sparse data. Exact methods or other approaches may sometimes be considered, but the registry does not say which method was planned or whether any alternative analysis was conducted. The stated status of the comparison is not estimable, so no method should be assumed to have produced a hidden result.
Over-dispersion is a general concern when counts vary more than a model expects, often because outcomes are more heterogeneous than the model allows. It is more directly relevant to count models than to this participant-level binary endpoint. The registry does not report a model or a dispersion estimate for this outcome. There is therefore no basis for claiming that over-dispersion was assessed or that a particular adjustment was used.
What does randomization support?
In general, random assignment is intended to make comparison groups similar on average with respect to both measured and unmeasured factors at allocation. It does not guarantee balance in every realized trial, particularly when the groups are small. The registry identifies the allocation as randomized, but provides no baseline characteristics or allocation procedure in the registry record reported for this analysis. No claim about balance or successful concealment can be made from the randomization label alone.
The registry lists no analyses for the posted outcomes. It does not report an intention-to-treat definition, a per-protocol population, handling of missing outcomes, covariate adjustment, or sensitivity analyses. These omissions matter because analysis choices can affect how randomized participants are represented and how robust estimates are. For the primary endpoint, the available result is the posted count in each arm and the registry’s statement that a binary comparison is not estimable.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Sham Transcranial Laser Therapy | 7 | 0 | 0.0% | 0.0% to 41.0% | 0.0% to 35.4% | 0.3% to 36.9% |
| Transcranial Laser Therapy | 5 | 0 | 0.0% | 0.0% to 52.2% | 0.0% to 43.4% | 0.4% to 45.9% |
R code and output
arm <- c("Sham Transcranial Laser Therapy", "Transcranial Laser Therapy")
n <- c(7, 5)
events <- c(0, 0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Sham Transcranial Laser Therapy 7 0 0.0 0.0 41.0 0.0 35.4 0.3 36.9
ARM Transcranial Laser Therapy 5 0 0.0 0.0 52.2 0.0 43.4 0.4 45.911. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical plan for handling multiple outcomes or multiple comparisons. It does not describe a hierarchy of hypotheses, a correction for multiplicity, or a distinction between confirmatory and exploratory tests. The brief summary states that the study aimed to assess safety and preliminary efficacy, but that description does not establish how any multiple testing was planned or interpreted.
No secondary outcome results are posted in the record. The primary endpoint has a stated timeframe, but the record does not explain whether other outcome time points or subgroup comparisons were planned. Without a reported analysis plan, it is not possible to determine which analyses were prespecified, whether any were omitted, or how the risk of chance findings was managed.
Missing-data procedures are not reported in the registry record. The endpoint results show the arm counts used for the outcome display, but the record does not state whether all randomized participants contributed an outcome, how unavailable assessments were handled, or whether any participants were excluded from the endpoint analysis. The enrollment figure and arm outcome counts do not, by themselves, identify an analysis population or establish complete follow-up.
The registry also does not describe an intention-to-treat, per-protocol, or safety population. It does not report imputation, sensitivity analyses, or reasons for missingness. These limitations leave uncertainty about the relationship between the randomized population and the participants included in each posted result. No assumptions about those procedures should be made from the reported counts alone.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sham Transcranial Laser Therapy | 3 | 7 | 42.9% |
| Transcranial Laser Therapy | 2 | 5 | 40.0% |
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 |
|---|---|
| Sham Transcranial Laser Therapy | 6 of 7 |
| Transcranial Laser Therapy | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Sham Transcranial Laser Therapy | Transcranial Laser Therapy |
|---|---|---|---|
| Neurological symptom | Nervous system disorders | 1 of 7 | 1 of 5 |
| Hypotension | Vascular disorders | 1 of 7 | 0 of 5 |
| Renal failure acute | Renal and urinary disorders | 0 of 7 | 1 of 5 |
| Cardiac failure congestive | Cardiac disorders | 0 of 7 | 1 of 5 |
| Clostridium colitis | Gastrointestinal disorders | 1 of 7 | 0 of 5 |
| Sepsis | Infections and infestations | 1 of 7 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sham Transcranial Laser Therapy | Transcranial Laser Therapy |
|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | 1 of 7 | 2 of 5 |
| Urinary Tract Infection | Renal and urinary disorders | 1 of 7 | 2 of 5 |
| Anaemia | Blood and lymphatic system disorders | 0 of 7 | 2 of 5 |
| Consitpation | Gastrointestinal disorders | 0 of 7 | 2 of 5 |
| Diarrhoea | Gastrointestinal disorders | 1 of 7 | 1 of 5 |
| Nausea | Gastrointestinal disorders | 1 of 7 | 1 of 5 |
| Oral candidiasis | Infections and infestations | 1 of 7 | 1 of 5 |
| Blood potassium decreased | Investigations | 2 of 7 | 0 of 5 |
| Hyperlipidaemia | Metabolism and nutrition disorders | 0 of 7 | 2 of 5 |
| Headache | Nervous system disorders | 2 of 7 | 0 of 5 |
Serious events with the highest arm-level rate: renal failure acute (20.0%), neurological symptom (20.0%), cardiac failure congestive (20.0%), hypotension (14.3%), clostridium colitis (14.3%).
The serious adverse-event figures are 3 participants affected among 7 at risk in the sham transcranial laser therapy arm and 2 among 5 at risk in the transcranial laser therapy arm. Other adverse events are reported for 6 among 7 at risk in the sham arm and 5 among 5 at risk in the active-therapy arm. These are descriptive arm counts. They are not an adjusted comparison, and the registry does not report confidence intervals or a statistical test for these figures.
The record also lists the following top serious adverse-event terms with their percentages: Renal failure acute, 20.0%; Neurological symptom, 20.0%; Cardiac failure congestive, 20.0%; Hypotension, 14.3%; Clostridium colitis, 14.3%; and Sepsis, 14.3%. The posted information does not identify the arm assignment or denominators for these terms, so the percentages should not be attributed to a particular arm or directly compared across arms.
Deaths are not reported in the registry record. Serious adverse-event counts are distinct from the primary endpoint count of symptomatic intracranial hemorrhages, and the record does not state that every serious event was caused by study treatment. These summaries should therefore be read as event reporting, not as proof of causation or as a complete characterization of safety.
13. What the Result Does, and Does Not, Mean
The result establishes that the registry records no symptomatic intracranial hemorrhages in either treatment arm during the specified 36-hour period from tPA initiation. It also establishes that the registry does not report an estimable two-arm comparison for this binary outcome. The descriptive finding is useful for understanding what was recorded in this trial, but it is not a precise estimate of the risk that would apply in a broader population.
It does not show that the risk is zero, that active laser therapy and sham therapy have equal safety, or that either approach changes the likelihood of hemorrhage. A zero count in both groups cannot rule out events that might occur in a larger group or over a different observation period. The record does not report a confidence interval or a comparative effect estimate that would quantify uncertainty.
It also does not establish efficacy. Although the study summary mentions preliminary efficacy, the posted primary endpoint is a safety outcome, and no efficacy analysis is reported in the registry record. The serious and other adverse-event counts add descriptive safety information, but they do not isolate treatment effects or establish that reported events were caused by the device or procedure.
The trial’s terminated status is relevant context, but the reason for termination is not reported in the registry record. It cannot be used to infer that the trial stopped because of harm, lack of efficacy, operational difficulty, or any other cause. The available statistical interpretation must therefore remain within the bounds of the posted endpoint counts, adverse-event summaries, and missing comparative analyses.
14. Why This Trial Matters Statistically
This trial illustrates how an apparently simple result—no recorded primary events in either arm—can leave the central comparative question unanswered. Counts describe the observed participants, while an effect estimate and its uncertainty are needed to assess how compatible the data are with meaningful differences between treatment groups. Here, the registry explicitly says that the binary comparison is not estimable.
The design also highlights the distinction between a trial’s stated aims and the outcomes that can be interpreted from its posted results. The brief summary refers to safety and preliminary efficacy, but the primary result available is a safety count and no efficacy analysis is posted. A stated aim is not itself evidence that the aim was answered.
Small randomized studies can be informative for feasibility and for describing observed events, but sparse outcomes limit how precisely comparative risks can be estimated. In this record, the primary event is absent in both arms, and the groups are small. The result should not be translated into an assertion of equivalence or absence of risk.
The record also demonstrates why transparent reporting of analysis populations, missing-data handling, statistical methods, and reasons for termination matters. Those details help readers distinguish a planned analysis from a descriptive registry entry and assess how much confidence to place in a result. Their absence does not negate the posted counts, but it constrains the conclusions that can be drawn from them.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry reports enrollment of 12, with primary endpoint arm counts of 7 for sham therapy and 5 for active therapy. These group sizes provide limited information about uncommon safety outcomes, and no events were recorded for the primary endpoint in either arm. The comparison is explicitly marked not estimable. There is no reported effect estimate, confidence interval, p-value, or adjusted analysis to quantify the difference or its precision.
The record does not report a sample-size justification, the planned statistical analysis, baseline characteristics, allocation procedures, or a detailed definition and adjudication process for symptomatic intracranial hemorrhage. It also does not describe analysis populations, missing data, protocol deviations, or sensitivity analyses. As a result, readers cannot assess those aspects of trial conduct and analysis from the registry entry.
The status is terminated, but the reason for termination is not reported in the registry record. The posted information does not explain whether termination affected recruitment, follow-up, or outcome ascertainment. The registry’s summary and arm descriptions also give different timing details about the laser procedure: feasibility within 6 hours of stroke onset in the brief summary, and treatment no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset in the arm descriptions. The record does not clarify this relationship.
Finally, the serious adverse-event terms are listed with percentages but without arm assignment or denominators in the available information. Deaths are not reported. These limitations mean that the adverse-event summaries cannot be used as a complete, arm-specific comparative safety analysis.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery — NCT01220739.
- Registry record last updated 2016-12-05; status last verified 2016-10.
- Results first posted 2016-12-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT01220739 is a randomized, quadruple-masked, parallel-group Phase 2 trial sponsored by the University of California, San Diego. It studied IV tPA followed by active transcranial laser therapy or sham transcranial laser therapy for acute ischemic stroke. The registry reports enrollment of 12, a start of 2011-06, primary completion in 2012-12, and a status of terminated.
The primary endpoint was symptomatic intracranial hemorrhages within 36 hours from tPA initiation. The registry records 0.0 participants with the event in each arm and says a two-arm binary comparison is missing or not estimable. Serious and other adverse-event counts are posted, but no comparative analysis is reported. The reason for termination, statistical analysis plan, missing-data procedures, and analysis populations are not reported in the registry record.