This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine (NCT00384774), a randomized phase 2 study. The primary outcome is Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00384774 |
| Phase | Phase 2 |
| Condition | Migraine |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 130 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with migraine who were randomized and received at least one dose of study drug. The primary endpoint’s stated analysis population is all such participants; further eligibility details are not reported in the registry record.
Intervention
Intravenous lasmiditan, assigned in escalating dose groups of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg.
Comparator
Intravenous placebo solution.
Primary question
How many participants in each study group had a reduction from moderate or severe headache at baseline to mild or no headache two hours after infusion began?
This is a short-term, symptom-response question in an acute migraine treatment study. The endpoint focuses on a change in headache intensity at a defined time after treatment initiation. It is not a question about long-term migraine control, recurrence across later attacks, or sustained benefit over an extended period.
The trial title describes adaptive treatment assignment and a group-sequential design, and the study summary says the aim was to evaluate a range of intravenous doses to select a dose range for further studies. The specific rules for dose assignment or any adaptations are not reported in the registry record, so the title alone does not establish how those features operated in practice. The available record also does not report a numerical primary outcome result for lasmiditan or placebo. Consequently, the clinical question can be described from the endpoint definition, but the posted record does not establish the observed size or precision of any difference between groups.
3. Trial Design
This was a phase 2, randomized, double-masked, parallel-group study of intravenous lasmiditan and placebo in acute migraine. The registry lists enrollment of 130 participants and a completed study. The recorded start was 2006-11, and primary completion was 2007-06. Eli Lilly and Company is listed as sponsor.
Participants assigned to lasmiditan received escalating doses in separate dose groups: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg or 45 mg. The comparator group received intravenous placebo solution. The study summary describes the purpose as evaluating a range of intravenous doses to select a dose range for further studies. Because several dose groups were included, the overall design is not simply a single lasmiditan dose compared with placebo. The primary result would need to be interpreted in light of the particular dose-group comparisons and analysis procedures, which are not reported in the registry record.
Randomization is intended to reduce systematic differences between assigned groups, while masking is intended to limit the influence of treatment knowledge on participants’ experiences and assessments. These are general design principles; the registry does not report the randomization sequence method, allocation concealment procedure, or who specifically was masked. Parallel-group assignment means treatment groups are followed as distinct groups rather than participants crossing from one treatment to another, as described by the registered model.
Although the official title refers to group-sequential and adaptive treatment assignment, the operational details are not reported in the registry record. In particular, the record does not describe stopping boundaries, interim decision rules, or how assignment probabilities may have changed. The number assigned to each dose group is not stated in the registry record for this account, and enrollment should not be treated as the number in any one comparison group.
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.
Only the first 6 of 7 groups are shown.
Overall Study
| Stage | Placebo | Lasmiditan 2.5 mg | Lasmiditan 5.0 mg | Lasmiditan 10 mg | Lasmiditan 20 mg | Lasmiditan 30 mg |
|---|---|---|---|---|---|---|
| STARTED | 42 | 4 | 12 | 24 | 28 | 16 |
| Received at Least 1 Dose of Study Drug | 42 | 4 | 12 | 24 | 28 | 16 |
| COMPLETED | 42 | 4 | 12 | 24 | 28 | 16 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least one dose of study drug.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All randomized participants who received at least one dose of study drug.
Only the first 6 of 8 groups are shown.
| Characteristic | Unit | Placebo | Lasmiditan 2.5 mg | Lasmiditan 5.0 mg | Lasmiditan 10 mg | Lasmiditan 20 mg | Lasmiditan 30 mg |
|---|---|---|---|---|---|---|---|
| Participants analysed | 42 | 4 | 12 | 24 | 28 | 16 | |
| Age, Continuous | Years | 40.3 (SD 13.1) | 46.8 (SD 14.0) | 39.2 (SD 8.8) | 34.5 (SD 10.3) | 38.9 (SD 10.1) | 40.3 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 38 | 3 | 10 | 21 | 24 | 14 |
| Sex: Female, Male: Male | Participants | 4 | 1 | 2 | 3 | 4 | 2 |
| Race/Ethnicity, Customized: Caucasian | Participants | 42 | 4 | 11 | 20 | 28 | 16 |
| Race/Ethnicity, Customized: Black | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Race/Ethnicity, Customized: Latin | Participants | 0 | 0 | 1 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: South-American | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Race/Ethnicity, Customized: Romanian | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Race/Ethnicity, Customized: Unknown or Not Reported | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Region of Enrollment: Netherlands | Participants | 3 | 0 | 1 | 3 | 1 | 0 |
| Region of Enrollment: Finland | Participants | 10 | 0 | 6 | 4 | 2 | 1 |
| Region of Enrollment: Germany | Participants | 29 | 4 | 5 | 17 | 25 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug, measured over 2 hours post dose.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with a headache response at two hours after initiation of the study-drug infusion. The registry defines response as a reduction in headache severity from moderate or severe at baseline to mild or no headache at the two-hour assessment. It is a binary outcome at the participant level: each participant either meets that response definition or does not.
This endpoint is used to capture a clinically interpretable change in headache intensity during the acute treatment period. A fixed assessment time makes the response definition specific, and the requirement for a change from baseline distinguishes response from simply having a low headache intensity at follow-up. The measure is based on headache intensities recorded in a participant diary.
Because the outcome is binary, a group comparison can describe the number or proportion of participants meeting the response definition. Such a comparison would need to account for which dose group is being compared with placebo and for the precision of the estimates. The endpoint description alone does not give those results. The number of responders, the group-specific response percentages, an estimated treatment contrast, and its confidence interval are not reported in the registry record. The analysis population is described as all randomized participants who received at least one dose of study drug; how missing diary assessments were handled is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its assessment time, but it does not report the primary endpoint results. There are no group-specific responder counts or response percentages in the registry entries, and no treatment contrast, confidence interval, or p-value is reported. Accordingly, the record does not permit a quantitative account of the primary comparison or how precisely it was estimated.
The question concerns a two-hour headache response after infusion initiation, not an outcome measured over a longer period. Even a reported difference at that time point would need to be interpreted as evidence about this particular endpoint and assessment window. It would not, by itself, describe sustained response, later recurrence, effects on other migraine symptoms, or outcomes across subsequent attacks.
The study included six lasmiditan dose groups and placebo. A result from one dose group would answer a different dose-specific question from a pooled or overall treatment comparison. The registry record does not report which dose comparisons were specified as primary, whether a dose-response analysis was planned, or how the multiple dose groups were incorporated into the primary analysis. Without those details and the outcome estimates, a dose ranking or dose-selection conclusion cannot be reconstructed.
The registry lists nine outcome measures and six analyses. The relationship between those outcomes and analyses, the statistical testing hierarchy, and any adjustment for multiple comparisons are not reported in the registry record. This matters because interpreting several dose groups and outcomes can involve more than one opportunity to identify an apparently notable result. General statistical principles call for clarity about which comparison was primary and how multiplicity was handled; the record does not provide that information.
The available safety information reports zero participants with serious adverse events and zero deaths in every listed group. It also reports counts in the other-adverse-event category, but does not include event terms in the registry record for this account. These counts should be read as descriptive safety information, not as a substitute for the unreported efficacy results. The group sizes differ, so raw counts alone do not establish comparative risk. The record does not report inferential comparisons or detailed event descriptions.
Overall, the record supports a description of the design, endpoint definition, and selected safety counts. It does not support a numerical conclusion about the primary headache-response comparison, the uncertainty around that comparison, or which dose range was selected. Those results and decision details are not reported in the registry record.
9. Statistical Methods Explained
The outcome and design information allow several statistical concepts to be explained, but the particular analysis procedures used for the primary endpoint are not reported in the registry record. The title’s reference to adaptive treatment assignment and group-sequential design is not a substitute for a statistical analysis plan. The following explanations are general and do not assert that a particular procedure was used in this trial.
What does a binary endpoint represent?
The primary endpoint classifies each participant according to whether the stated headache-response definition was met at the assessment time. In a binary outcome, the basic group summary is the number meeting the definition relative to the number assessed or included in the analysis. The registry names the outcome as a count of participants and defines the analysis population as randomized participants who received at least one dose. It does not report the response counts or clarify how participants without an assessable diary entry were handled.
Groups can be compared using a difference in response proportions, a ratio of proportions, an odds ratio, or another prespecified measure. These measures answer related but distinct questions and have different interpretations. The registry record does not report which effect measure was used, so no particular measure should be attributed to the trial. A point estimate describes the observed contrast, while an interval estimate communicates uncertainty about the contrast under the assumptions of the analysis.
What does a confidence interval convey?
As a general statistical explanation, a confidence interval is a range of values compatible with the observed data under a specified analysis procedure. Its width reflects precision: a narrower interval indicates greater precision than a wider one under the same framework. It does not show the range of outcomes for individual participants, and it is not a guarantee that the true effect lies within the particular interval. No confidence interval for the primary endpoint is reported in the registry record.
A p-value, when used, addresses how compatible the data are with a specified null hypothesis under the model and assumptions. It does not measure the size or clinical importance of an effect. Nor does it replace an effect estimate and its uncertainty. The registry record does not report a primary endpoint p-value or state the test used.
Why do dose groups and multiplicity matter?
There are six lasmiditan dose groups and a placebo group in the listed treatment descriptions. Comparing each dose with placebo creates multiple potential contrasts. When several hypotheses are tested, the chance of at least one apparently unusual result can increase if each is assessed without an appropriate multiplicity strategy. General approaches include defining a primary contrast in advance, using a testing hierarchy, or adjusting inference across a family of comparisons. Which approach, if any, was used is not reported in the registry record.
Adaptive assignment and group-sequential methods can involve planned changes to treatment allocation or decisions based on accumulating data. Valid interpretation depends on the design rules, timing of analyses, and methods for accounting for repeated looks or adaptive decisions. Although these concepts appear in the official title, the actual rules, interim analyses, and adjustment procedures are not reported in the registry record. It would be inappropriate to infer them from the title alone.
How should planning calculations be read?
Planning illustrations based on an observed effect are not observed power and do not describe what the original trial was designed to detect. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are conditional illustrations. They do not establish the original sample-size justification, which is not reported in the registry record. They also do not repair the absence of primary outcome estimates or demonstrate that a study had adequate power.
For a binary endpoint, the precision of a comparison depends in part on the number of participants and the distribution of responses across groups. Unequal group sizes can lead to different precision across dose comparisons. The overall enrollment of 130 does not disclose how many participants were assigned to each treatment group or included in each endpoint analysis. Group-specific denominators for the primary outcome are not reported in the registry record.
What is known about analysis populations and missing data?
The primary endpoint description names all randomized participants who received at least one dose as the analysis population. This is a stated population definition, but it does not provide a full account of exclusions, protocol deviations, or the handling of missing assessments. In general, missing outcome data can affect estimates when the probability of missingness is related to treatment or outcome. Common strategies make different assumptions, so the method should be reported and examined for sensitivity. The missing-data approach is not reported in the registry record.
The registry record also does not report whether the primary analysis adjusted for baseline headache severity or other variables, how any model assumptions were assessed, or whether sensitivity analyses were performed. These omissions limit independent evaluation of the analysis. The endpoint definition and design can be described, but the statistical evidence for the primary question cannot be reconstructed without the outcome data and analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is clearly defined as headache response at two hours after infusion initiation. However, the registry record lists nine outcome measures and six analyses without describing their hierarchy or how they relate to each other. It does not report whether the primary comparison was prespecified for each lasmiditan dose, whether a particular dose was the main focus, or how multiplicity across doses and outcomes was addressed. These details are important when interpreting a study with several dose groups, because multiple comparisons can complicate the meaning of nominal statistical significance.
The registry record does not report an interim-analysis schedule, stopping criteria, or adjustments for repeated analyses. This is especially relevant because the official title describes a group-sequential, adaptive treatment assignment study. The title indicates the design terminology, but it does not establish the implemented decision rules or analysis methods.
The primary analysis population is stated as all randomized participants who received at least one dose of study drug. The record does not provide endpoint-specific denominators, missing diary counts, or a method for handling missing outcomes. It also does not explain exclusions after randomization or report sensitivity analyses for missing data. As a result, the extent to which missingness or analysis-population decisions could affect the primary estimate cannot be assessed from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 0 | 42 | 0.0% |
| Lasmiditan 2.5 mg | 0 | 4 | 0.0% |
| Lasmiditan 5.0 mg | 0 | 12 | 0.0% |
| Lasmiditan 10 mg | 0 | 24 | 0.0% |
| Lasmiditan 20 mg | 0 | 28 | 0.0% |
| Lasmiditan 30 mg | 0 | 16 | 0.0% |
| Lasmiditan 45 mg | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 42 |
| Lasmiditan 2.5 mg | 0 of 4 |
| Lasmiditan 5.0 mg | 0 of 12 |
| Lasmiditan 10 mg | 0 of 24 |
| Lasmiditan 20 mg | 0 of 28 |
| Lasmiditan 30 mg | 0 of 16 |
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 |
|---|---|
| Placebo | 18 of 42 |
| Lasmiditan 2.5 mg | 2 of 4 |
| Lasmiditan 5.0 mg | 3 of 12 |
| Lasmiditan 10 mg | 17 of 24 |
| Lasmiditan 20 mg | 19 of 28 |
| Lasmiditan 30 mg | 13 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Lasmiditan 2.5 mg | Lasmiditan 5.0 mg | Lasmiditan 10 mg | Lasmiditan 20 mg | Lasmiditan 30 mg |
|---|---|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | 6 of 42 | 2 of 4 | 1 of 12 | 8 of 24 | 7 of 28 | 3 of 16 |
| Paraesthesia | Nervous system disorders | 0 of 42 | 0 of 4 | 0 of 12 | 5 of 24 | 8 of 28 | 3 of 16 |
| Fatigue | General disorders | 4 of 42 | 0 of 4 | 1 of 12 | 1 of 24 | 5 of 28 | 3 of 16 |
| Discomfort | General disorders | 1 of 42 | 0 of 4 | 0 of 12 | 2 of 24 | 3 of 28 | 3 of 16 |
| Nausea | Gastrointestinal disorders | 2 of 42 | 0 of 4 | 0 of 12 | 0 of 24 | 3 of 28 | 1 of 16 |
| Feeling of relaxation | General disorders | 0 of 42 | 0 of 4 | 0 of 12 | 0 of 24 | 2 of 28 | 3 of 16 |
| Vertigo | Ear and labyrinth disorders | 0 of 42 | 0 of 4 | 0 of 12 | 1 of 24 | 1 of 28 | 2 of 16 |
| Chest pain | General disorders | 2 of 42 | 0 of 4 | 0 of 12 | 0 of 24 | 0 of 28 | 1 of 16 |
| Feeling hot | General disorders | 2 of 42 | 0 of 4 | 0 of 12 | 0 of 24 | 0 of 28 | 1 of 16 |
| Formication | Nervous system disorders | 0 of 42 | 0 of 4 | 0 of 12 | 0 of 24 | 0 of 28 | 3 of 16 |
The registry reports serious adverse-event and death counts by treatment group. Serious adverse events are reported for zero participants in each listed group, and deaths are reported as zero in each group. The denominators at risk are listed in words alongside the counts of participants in the other-adverse-event category.
- Placebo: 42 at risk for serious events and 42 for other events; zero serious events, 18 in the other category, and zero deaths.
- Lasmiditan 2.5 mg: 4 at risk; zero serious events, 2 in the other category, and zero deaths.
- Lasmiditan 5.0 mg: 12 at risk; zero serious events, 3 in the other category, and zero deaths.
- Lasmiditan 10 mg: 24 at risk; zero serious events, 17 in the other category, and zero deaths.
- Lasmiditan 20 mg: 28 at risk; zero serious events, 19 in the other category, and zero deaths.
- Lasmiditan 30 mg: 16 at risk; zero serious events, 13 in the other category, and zero deaths.
- Lasmiditan 45 mg: 4 at risk; zero serious events, 3 in the other category, and zero deaths.
The registry lists no top serious-event terms. The registry entries available do not identify the events included in the other category or give event-level descriptions. These are counts, not adjusted comparisons, and the differing group sizes mean counts alone are not a measure of relative risk. The record does not report statistical comparisons of these safety outcomes.
12. What the Result Does, and Does Not, Mean
The primary endpoint is a two-hour, diary-based measure of improvement in headache intensity from moderate or severe to mild or no headache. This definition identifies what the trial sought to measure. It does not itself show how many participants met the definition or whether response differed between lasmiditan and placebo.
The registry describes a randomized, double-masked, parallel phase 2 study enrolling 130 participants, with intravenous lasmiditan dose groups and an intravenous placebo group. The study summary states that the aim was to evaluate a range of doses to select a dose range for further studies. The record does not report the dose-selection result or the numerical primary endpoint findings. Therefore, the available information does not establish the magnitude, direction, or precision of a treatment contrast.
Even when a trial reports a difference, its interpretation depends on the endpoint, comparison, analysis population, uncertainty, and design. A result at two hours would address that specific time point; it would not by itself establish sustained response or effects on all other migraine symptoms. This study also lists secondary outcomes concerning headache response over a broader time window, headache freedom, sustained outcomes, symptoms, clinical disability, rescue medication, and patient global impression. Their presence in the registry does not provide their results.
The safety record reports no serious adverse events or deaths in the listed groups, alongside counts in the other-adverse-event category. Those observations describe the registry’s recorded counts and do not replace detailed event information or comparative analyses. The listed group sizes are not equal, and the record does not report inferential safety comparisons.
In short, the record establishes the study question, design features, endpoint definition, and selected safety counts. It does not provide enough primary outcome data or statistical detail to make a quantitative judgment about the observed headache-response contrast, its uncertainty, or the dose range selected.
13. Why This Trial Matters Statistically
This trial is statistically notable for the combination of several intravenous dose groups, a placebo comparator, and design terminology referring to adaptive treatment assignment and group-sequential methods. Such designs can be useful when dose selection is a central objective, but their interpretation depends on prespecified allocation and decision rules. Those operational details are not reported in the registry record, so the design label alone cannot establish how adaptive decisions were made or how inference was protected.
The primary outcome is a binary response assessed at a fixed time after infusion initiation. That creates a direct, interpretable endpoint, but the analysis still depends on the response counts in each group, the comparison measure, and the treatment of missing assessments. These results and procedures are not reported in the registry record. The study’s enrollment figure does not indicate the number analyzed in any specific dose comparison.
Multiple dose groups also bring a multiplicity question. Testing several doses against placebo can generate a family of comparisons, and the interpretation of estimates depends on whether and how that family was handled. The registry lists multiple outcomes and analyses but does not report a hierarchy or adjustment strategy. This is a limitation for assessing the strength of any individual finding, even though the primary question itself is clearly defined.
The study summary frames the objective as selecting a dose range for further studies. That makes transparent reporting of dose-specific estimates, uncertainty, and selection rules especially important. The registry record’s endpoint definition is informative, but without primary results and analysis details, the statistical basis for any dose-selection decision cannot be evaluated.
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 for interpreting this record is that primary endpoint results are not reported in the registry record. There are no responder counts or estimates of the comparison between placebo and any lasmiditan dose, and no confidence intervals or p-values are reported. The effect’s direction, magnitude, and precision therefore cannot be described.
The record identifies a randomized, double-masked, parallel study and names six lasmiditan dose groups, but it does not give group-specific primary endpoint denominators in the registry record. The total enrollment of 130 does not show how participants were distributed across groups or how many contributed to the endpoint analysis. The randomization procedure, allocation concealment, and details of masking are also not reported in the registry record.
The official title refers to adaptive treatment assignment and a group-sequential design, but the operational rules are not reported. There is no information about interim analyses, stopping boundaries, or adjustments for repeated looks. The record also does not explain the primary comparison strategy across the several dose groups, or how multiplicity across the listed outcomes and analyses was handled.
Although the primary analysis population is described as randomized participants who received at least one dose, missing outcome handling, exclusions, and sensitivity analyses are not reported in the registry record. This prevents assessment of how incomplete diary data may have affected the endpoint. Finally, detailed descriptions of events in the other-adverse-event category are absent in the registry record, and the serious-event terms list is empty. These reporting gaps limit evaluation of both efficacy and safety evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine — NCT00384774.
- Registry record last updated 2019-12-02; status last verified 2018-01.
- Results first posted 2019-12-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT00384774, a completed phase 2 randomized, double-masked, parallel study sponsored by Eli Lilly and Company. Enrollment was 130. The recorded study start was 2006-11, and primary completion was 2007-06.
The study evaluated intravenous lasmiditan at 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg against intravenous placebo in acute migraine. The primary endpoint was the number of participants with headache response at two hours after infusion initiation, defined as a reduction from moderate or severe headache at baseline to mild or no headache. The stated analysis population was randomized participants who received at least one dose.
The primary outcome results, detailed statistical analysis methods, missing-data procedures, and adaptive or group-sequential decision rules are not reported in the registry record. The safety counts report zero serious adverse events and zero deaths in each listed group, alongside counts in the other-adverse-event category.