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 Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin (NCT04932096), a randomized phase 2 study. The primary outcome is Sleep Disturbances Scale for Children.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04932096 |
| Phase | Phase 2 |
| Condition | Traumatic Brain Injury, Critical Illness, Sleep |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 21 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oregon Health and Science University |
| Results posted | Yes |
2. Clinical Question
Population
Children hospitalized with traumatic brain injury were the intended population. The registry also lists critical illness and sleep among the conditions. Enrollment was 21. The record does not report further eligibility details or a more specific description of participants included in the primary-outcome results.
Intervention
The intervention was melatonin, started during hospitalization and continued after discharge. The registry describes nightly doses of 3mg or 5mg based on patient size, given 1 hour before bedtime for 30 days. Sleep education was also planned for participants.
Comparator
The control group received placebo, and the trial description says participants in both groups received sleep education. The record describes random assignment with a goal of equal group sizes. It does not report the details of how the allocation sequence was generated or concealed.
Primary question
The primary outcome was the Sleep Disturbances Scale for Children at 1-month, reported as a T-score. The study aimed to evaluate whether the intervention was feasible and acceptable, and to assess its effect on sleep disturbances. The registry record does not report the group-specific primary-outcome values or an inferential comparison, so the primary question cannot be answered from the posted results described in the record.
This is a pilot randomized trial, not a record of a definitive efficacy comparison. The study also assessed adherence and sleep-related measures, with exploratory global health outcomes described in the trial summary. The central statistical distinction is between measuring whether a trial can be carried out and estimating an intervention effect. The registry describes both aims, but the primary outcome information available does not provide a numerical effect estimate or its precision. Feasibility and acceptability results are likewise not reported in the registry record in the information available for this analysis.
3. Trial Design
The registry identifies this as a Phase 2, randomized, quadruple-masked, parallel-group trial. The sponsor was Oregon Health and Science University. Enrollment was 21. The record lists the study as completed, with a start date of 2023-01-02 and primary completion date of 2025-03-01. These design and status details describe how the study was registered; they do not by themselves establish what the outcome results show.
Participants were assigned to melatonin or placebo. The intervention description specifies melatonin doses of 3mg or 5mg based on patient size, taken nightly 1 hour before bedtime for 30 days. The trial summary says sleep education was provided to participants in both groups. It describes follow-up after consent, with outcome assessments at hospital discharge and 1-month. The primary endpoint is specified at 1-month after hospital discharge.
Masking is recorded as quadruple, but the registry record does not identify which roles were masked or describe how masking was maintained. The record also does not report the randomization procedure, allocation concealment, protocol deviations, or whether the intended allocation balance was achieved. Those details matter when evaluating the risk of bias, but their absence from the registry information should not be filled in by assumption.
The primary endpoint is the Sleep Disturbances Scale for Children, and the trial lists 23 outcome measures. Secondary outcomes include adherence, fatigue, chronotype, sleep latency, total sleep time, wake after sleep onset, and number of night awakenings. Actigraphy and questionnaires are described as measurement approaches. The registry lists zero analyses. That does not establish that no analyses were conducted; it means the registry record does not include analysis records in the information. The primary outcome is not reduced to a single comparison because it has several categories or time points.
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 | Melatonin | Placebo |
|---|---|---|
| STARTED | 10 | 11 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 1 | 2 |
Reasons for not completing this period:
| Reason | Melatonin | Placebo |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Partial completion (did not complete primary outcome survey) | 0 | 1 |
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 | Melatonin | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 11 | 21 | |
| Age, Continuous | years | 10.3 (9.7 to 13.6) | 12.8 (7.7 to 14.8) | 10.7 (8.3 to 14.2) |
| Sex: Female, Male: Female | Participants | 5 | 4 | 9 |
| Sex: Female, Male: Male | Participants | 5 | 7 | 12 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 | 10 | 20 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 8 | 8 | 16 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Medicaid Insurance Status: Medicaid | Participants | 6 | 6 | 12 |
| Medicaid Insurance Status: Private Insurance | Participants | 4 | 5 | 9 |
| Admission Glasgow Coma Scale Score: Mild, score 13-15 | Participants | 7 | 9 | 16 |
| Admission Glasgow Coma Scale Score: Moderate, score 9-12 | Participants | 1 | 0 | 1 |
| Admission Glasgow Coma Scale Score: Severe, score 3-8 | Participants | 2 | 2 | 4 |
| Pre-injury medical condition present | Participants | 3 | 2 | 5 |
| Pre-injury psychological diagnosis present | Participants | 0 | 1 | 1 |
| Pre-injury neurodevelopmental condition present | Participants | 3 | 3 | 6 |
| Skull fracture present at admission | Participants | 9 | 6 | 15 |
| Intracranial injury on imaging present at admission | Participants | 8 | 6 | 14 |
| Other injuries (non-brain) present at admission | Participants | 3 | 6 | 9 |
| Inpatient Rehabilitation Discharge Disposition | Participants | 1 | 0 | 1 |
| Sleep Disturbances Scale for Children Total score | T-score | 60 (55 to 64) | 63 (56 to 76) | 60 (48.5 to 74.5) |
6. Primary Endpoint
The registry lists the primary outcome as Sleep Disturbances Scale for Children, measured over 1-month.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | T-score |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is the Sleep Disturbances Scale for Children (SDSC), assessed at 1-month and expressed as a T-score. It is a 26-item parent-proxy questionnaire about sleep. Higher scores indicate greater disturbance and risk for clinically important sleep disorders. Each item is scored from 1 through 5, with possible raw total scores from 26 to 130. Raw scores are converted to measure-defined T-scores for the total score and six subscales: Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis. Higher T-scores indicate worse dysfunction; T-scores greater than 60 generally indicate clinically significant dysfunction in the total score and each subscale.
A standardized score can help describe a participant’s sleep symptoms relative to the measure’s defined scale. The parent-proxy format also allows caregivers to report observed sleep behaviors. These features make the SDSC relevant to the trial’s question about sleep disturbance after traumatic brain injury. However, a score is an outcome measure, not by itself proof of a treatment effect. Interpretation of a randomized comparison would require the group results, a clearly specified comparison, and an account of uncertainty.
The registry specifies the primary outcome as a median with an inter-quartile range, but the group-specific medians and inter-quartile ranges are not reported in the registry record. The record also does not provide a numerical comparison between groups. Consequently, the direction, size, and precision of any difference on this measure cannot be described from the available outcome information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized pilot trial of melatonin compared with placebo, with sleep education planned for both groups. It identifies the SDSC T-score at 1-month as the primary outcome and states that higher scores reflect worse sleep dysfunction. However, the primary outcome information does not include group-specific medians, inter-quartile ranges, an effect estimate, or a confidence interval. The record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. There is therefore no single primary-outcome contrast to interpret.
Without a contrast, it is not possible to describe whether the posted primary outcome favors either group, how large any difference might be, or how precisely an effect was estimated. Those are separate questions. An estimate describes the observed difference; a confidence interval describes the range of values compatible with the data and the assumptions used to calculate it. A narrow interval generally indicates greater precision than a wide interval, but the registry record does not report an interval for this endpoint.
The trial’s pilot framing is important. Feasibility and acceptability were among the stated aims, alongside assessment of sleep disturbance. A pilot study can inform whether recruitment, adherence, follow-up, and outcome collection are workable. Those objectives are not interchangeable with a well-powered estimate of clinical effect. Although the summary describes feasibility and acceptability outcomes, their results are not reported in the registry record.
The registry lists 21 enrolled participants, but enrollment alone does not reveal how many contributed primary-outcome data, whether missing observations occurred, or how outcomes were handled. The actual analysis population and missing-data procedures are not reported in the registry record. The intended goal of equal group sizes is not evidence that equal numbers were analyzed.
The record lists 23 outcome measures and zero analyses. This makes it especially important not to select a favorable result or infer a primary comparison from outcome descriptions alone. The record also contains no inferential plan, such as a specified model, adjustment strategy, or method for handling multiple outcomes. These methods are not reported in the registry record.
Any planning illustrations based on an observed effect should be read as hypothetical design calculations, not as observed power or evidence that the trial established an effect. The record’s stated planning assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of an observed effect. Those are described as planning assumptions, not as the trial’s own design justification. No numerical planning results are available in the information, and no sample-size figure should be treated as a result of this trial.
Overall, the record establishes the trial’s purpose, registered design, and outcome definitions. It does not provide enough primary-outcome results to estimate or judge the size and precision of a melatonin-versus-placebo difference. That is a limitation of the registry information available for statistical interpretation, not a basis for assuming either a positive or a null result.
9. Statistical Methods Explained
The registry describes a randomized, quadruple-masked, parallel-group study. Random assignment is intended to make the comparison between groups less vulnerable to systematic differences in participant characteristics. Masking can reduce the influence of expectations on care, reporting, or assessment. These are general statistical and design principles. The registry does not report the randomization sequence method, the allocation-concealment procedure, or which people were masked, so the specific safeguards used in this trial cannot be assessed from this record.
What does randomization contribute?
In general, randomization makes treatment assignment a chance process rather than a choice based on prognosis or participant characteristics. This helps support a causal interpretation of a group comparison when the assigned groups are analyzed appropriately and when losses to follow-up, deviations, and outcome measurement are handled transparently. It does not ensure that every measured or unmeasured characteristic will be balanced in a small trial. Nor does randomization make a comparison interpretable when the outcome data and analysis are not reported.
The trial planned melatonin versus placebo, with sleep education for both groups. The parallel design means participants were assigned to a group rather than crossing between interventions. The record describes the melatonin schedule and follow-up, but does not report adherence results, treatment discontinuations, or protocol deviations. Those details can affect what intervention contrast a result represents.
Why report medians and inter-quartile ranges?
The primary endpoint is specified as a median with an inter-quartile range. In general, the median describes the middle of an ordered set of observations, while the inter-quartile range describes the spread of the central portion of those observations. These summaries can be useful when a distribution is skewed or when extreme values make a mean less representative of a typical observation. A median and inter-quartile range do not by themselves provide an estimate of the difference between randomized groups, a test of that difference, or its uncertainty. The registry record does not report the group-specific summaries or a comparative analysis for the SDSC outcome.
What does a T-score represent?
The SDSC converts raw questionnaire scores to measure-defined T-scores. The registry states that these scores have a mean of 50 and a standard deviation of 10 in the measure’s reference scale. This is a property of the score definition, not a description of the trial participants’ observed scores. Higher scores represent worse dysfunction, and scores greater than 60 generally indicate clinically significant dysfunction according to the measure description. A threshold can aid interpretation, but it does not replace reporting the observed score distribution or a randomized comparison.
How should uncertainty be considered?
In general, a point estimate is the value calculated from observed data, while a confidence interval communicates uncertainty around that estimate under a statistical model. A confidence interval is not a guarantee that the true effect falls within its limits, and its interpretation depends on the design and analysis assumptions. The registry record does not report an effect estimate or confidence interval for the primary outcome. It is therefore not possible to characterize statistical precision or distinguish a precise estimate from an imprecise one.
A p-value, when reported, addresses how compatible the observed data are with a specified null model under its assumptions; it is not a measure of effect size or clinical importance. The registry information does not include a primary-outcome p-value or analysis record. No conclusion about statistical significance should be inferred from the enrollment count, the completed status, or the outcome definitions.
What do the planning assumptions mean?
The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated target effect is a fraction of the observed effect. These are explicitly planning illustrations rather than the trial’s own design justification. Sample-size calculations of this kind ask what size a future study might need under selected assumptions. They are not observed power, and they do not show that the current study had adequate power. Their usefulness depends on the stability and relevance of the effect estimate used as the basis, and that effect estimate is not included in the primary-outcome information.
More generally, a planning calculation is sensitive to the selected target effect, variability, significance threshold, allocation, and analysis method. Small changes in assumptions can change a calculated sample-size requirement. A planning illustration cannot substitute for transparent reporting of the trial’s observed outcomes and uncertainty.
Why can multiple outcomes complicate interpretation?
The registry lists 23 outcome measures, including the primary SDSC outcome and secondary measures related to adherence, fatigue, chronotype, and sleep. When investigators examine many outcomes or time points, the chance of encountering an apparently notable result by chance can increase. This is the general issue of multiplicity. Statistical approaches can address it through a prespecified hierarchy, adjustment, or a clear distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity strategy or an analysis plan. The number of listed outcomes alone does not reveal which analyses were planned, performed, or prioritized.
Many methods could be appropriate for particular outcome distributions or study questions, but method choice requires details that are not reported in the registry record. It would be inappropriate to assume a model, an adjustment, or a missing-data procedure. The design description and outcome definitions can be explained; the statistical analysis actually used cannot be reconstructed from those details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 23 outcome measures and describes several sleep-related outcomes and time points. It does not report a statistical plan for prioritizing these outcomes, controlling multiplicity, or distinguishing confirmatory from exploratory comparisons. In general, evaluating many outcomes can increase the chance of finding an apparently notable result by chance. A prespecified hierarchy or other approach can clarify how multiple comparisons are interpreted. No such approach is reported in the registry record, so the status of any unreported comparisons cannot be assessed.
The primary outcome is not reduced to one comparison because it has several categories or time points. The registry record does not include the group-specific primary-outcome summaries or a single inferential comparison. It also does not report confidence intervals or p-values for that endpoint. Without a defined comparison, the primary endpoint cannot be interpreted as an estimated treatment effect.
Enrollment is reported as 21, but the number with observed primary-outcome data, the analysis population, and reasons for missing data are not reported in the registry record. The record does not state whether participants were analyzed according to randomized assignment, whether any participants were excluded, or how missing outcomes were handled. In general, missing data can reduce precision and can bias a comparison when the probability of missingness is related to outcome or group assignment. The direction and extent of any such impact cannot be determined without information on missingness and the analysis.
These omissions do not establish that multiplicity or missing data were mishandled. They mean the registry record does not provide enough detail to evaluate those aspects of the analysis.
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 |
|---|---|---|---|
| Melatonin | 1 | 10 | 10.0% |
| Placebo | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Melatonin | 0 of 10 |
| Placebo | 0 of 11 |
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 |
|---|---|
| Melatonin | 4 of 10 |
| Placebo | 2 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Melatonin | Placebo |
|---|---|---|---|
| Readmission to hospital | Nervous system disorders | 1 of 10 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Melatonin | Placebo |
|---|---|---|---|
| Headaches | Nervous system disorders | 2 of 10 | 2 of 11 |
| Behavior change with increased anxiety | General disorders | 0 of 10 | 2 of 11 |
| Fatigue | General disorders | 0 of 10 | 1 of 11 |
| double vision | Eye disorders | 1 of 10 | 0 of 11 |
| motion sickness | Ear and labyrinth disorders | 1 of 10 | 0 of 11 |
| nightmares | Psychiatric disorders | 1 of 10 | 0 of 11 |
| tinnitus | Ear and labyrinth disorders | 1 of 10 | 0 of 11 |
| itching | Skin and subcutaneous tissue disorders | 1 of 10 | 0 of 11 |
| Appetite change | Gastrointestinal disorders | 1 of 10 | 0 of 11 |
Serious events with the highest arm-level rate: readmission to hospital (10.0%).
The adverse-event information lists serious events and other adverse events separately by group. For melatonin, the record gives 10 at risk and 1 affected for serious events, and 10 at risk and 4 affected for other adverse events. For placebo, it gives 11 at risk and 0 affected for serious events, and 11 at risk and 2 affected for other adverse events. Deaths are listed as 0 in each group. These are event-record counts as presented; they should not be converted into a comparative effect estimate without a defined analysis and fuller context.
The listed leading serious-event term is “Readmission to hospital,” with 10.0% attached. The registry record does not specify the group or denominator for that percentage in the information. The term should therefore not be assigned to one group or treated as a between-group rate.
Adverse-event counts alone do not indicate whether an event was caused by the intervention, how severe or persistent it was, or whether the groups differed beyond what could occur by chance. The record does not provide event narratives, timing, exposure duration, or a formal safety comparison. These figures describe what is registered, not a complete safety assessment and not individualized medical guidance.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized pilot trial was conducted to study melatonin compared with placebo after pediatric traumatic brain injury. It specifies the intervention schedule, the intended comparator, and the SDSC T-score at 1-month as the primary outcome. It also describes feasibility, acceptability, and other sleep-related measures as study aims. These details define the research question and measurement approach.
The record does not provide the primary-outcome group summaries, a comparative effect estimate, or an interval describing its precision. It therefore does not show, in the information available for this analysis, whether the observed primary outcome differed between groups or how uncertain such a difference would be. The absence of a reported estimate is not evidence that the groups were the same, and it is not evidence that one intervention performed better.
The pilot designation also limits what should be inferred. Pilot studies commonly address whether study procedures can be carried out and whether measures can be collected, as well as exploring outcome patterns. Their results can inform the design of later research, but a pilot’s enrollment and completion status do not establish that its effect estimate is precise or definitive. In this case, the registry describes feasibility and acceptability aims but does not report their results in the information.
The adverse-event record lists counts by group, including no deaths in either group, but it does not provide the context needed for a comparative safety conclusion. The leading serious-event term carries a percentage whose group and denominator are not specified. Those entries should be read descriptively, not as proof of causation or as a complete account of safety.
Accordingly, the most defensible interpretation is limited: the trial’s registered design and outcome definitions are available, but the primary outcome cannot be evaluated statistically from the reported details. No claim about benefit, lack of benefit, or clinical use follows from the enrollment, design, or adverse-event counts alone.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that matter in clinical research. First, its pilot purpose combines implementation questions with an outcome question. Feasibility and acceptability can help determine whether a larger study is workable, while an intervention-effect estimate asks how groups differ and how precisely that difference is known. These aims require clear outcome reporting because they answer different questions.
Second, the primary outcome is a parent-proxy sleep questionnaire reported as a median and inter-quartile range. That summary can describe the distribution of scores, but a randomized comparison requires more than describing the measure. Readers need group-specific results and a clearly defined contrast, together with an uncertainty estimate. Those comparative results are not reported in the registry record.
Third, the trial lists 23 outcome measures. Multiple outcomes can be useful in a pilot, particularly when assessing different dimensions of sleep and participant experience. But without a reported analysis plan, readers cannot tell how outcomes were prioritized or how exploratory findings should be distinguished from confirmatory conclusions. Transparent reporting helps prevent overemphasis on isolated results.
Finally, a completed study and a stated enrollment do not indicate how many participants contributed data to each outcome or how missing observations were handled. Clear accounting of outcome availability, analysis populations, and safety events would help readers judge the reliability and scope of the results. The registry record establishes a clinically focused research question and trial design, while leaving these statistical interpretation details unreported.
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 main trial-specific limitation for interpretation is that the registry record does not report the primary SDSC group summaries or a comparative estimate at 1-month. Because the outcome is not reduced to one comparison, its direction, magnitude, and precision cannot be assessed from this record. The measure description explains what higher scores mean, but does not substitute for observed results.
The record lists 23 outcome measures and zero analyses. It does not report which outcomes were analyzed, which were considered primary in the analysis, or how multiple outcomes and time points were handled. This makes it difficult to determine how any eventual result should be interpreted relative to the registered aims. It also does not report a full statistical analysis plan.
The number of participants with observed data for each outcome, analysis-population definitions, participant flow, and missing-data methods are not reported in the registry record. The registry gives an enrollment of 21, but enrollment does not establish the amount of analyzable data for a particular endpoint. Details about adherence, withdrawals, protocol deviations, and the extent to which masking was maintained are also not reported in the information available.
Safety information is limited to group counts and a serious-event term with a percentage whose group and denominator are unspecified. The record does not include enough detail to interpret timing, attribution, or event-level context. Finally, the planning assumptions describe illustrations rather than the trial’s own design justification, and no numerical planning results are included in the information. These limitations concern what can be evaluated from the registry record; they do not establish that the study methods or conduct were deficient.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin — NCT04932096.
- Registry record last updated 2025-08-20; status last verified 2025-08.
- Results first posted 2025-08-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04932096 is a completed Phase 2, randomized, quadruple-masked, parallel-group pilot trial sponsored by Oregon Health and Science University. Enrollment was 21. The study compared melatonin with placebo, with sleep education described for both groups. The melatonin schedule was nightly for 30 days, at 1 hour before bedtime, with a dose of 3mg or 5mg based on patient size.
The primary outcome was the Sleep Disturbances Scale for Children T-score at 1-month. The registry lists 23 outcome measures and zero analyses; the primary outcome is not reduced to one comparison. Group-specific primary-outcome results, effect estimates, and uncertainty are not reported in the registry record. The record also lists adverse-event counts by group and no deaths in either group. The available information describes the design and measures but does not permit a statistical conclusion about the primary outcome.