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 Drivers of Suicide Mobile App Study (NCT05427734), a randomized na study. The primary outcome is Change in Self-Injurious Thoughts and Behaviors Interview-Revised.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05427734 |
| Phase | NA |
| Condition | Suicide, Suicide, Attempted, Suicidal Ideation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 127 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Evidence-Based Practice Institute, Seattle, WA |
| Results posted | Yes |
2. Clinical Question
Population
Adults described in the registry summary as suicidal and 22 years and older, who may also be experiencing alcohol misuse. The record lists suicide, suicide attempt, suicidal ideation, alcohol use disorder, alcoholism, alcohol abuse, and screening and brief interventions among the conditions associated with the study. The registry record does not report detailed eligibility criteria, including how suicidal ideation or alcohol misuse was defined for enrollment.
Intervention
WisePath for Adults, a mobile app described as supporting people during challenging moments and behavioral concerns. The summary identifies depression, sleep problems, feelings of wanting to die or self-harm, and alcohol misuse as concerns the app is designed to address. The full app content and its delivery details are not reported in the registry record.
Comparator
An active-control condition comprising a suicide-prevention self-help app and an electronic wellness-resources brochure. The summary describes links to health and wellness materials, psychoeducation about suicide and depression, recovery-focused resources, and contact information for the 988 Suicide & Crisis Lifeline.
Primary question
How did scores on the Self-Injurious Thoughts and Behaviors Interview-Revised change from baseline through the scheduled follow-ups in the two randomized groups? The primary outcome is described across baseline, 4 weeks, 8 weeks, and 12 weeks. Numerical group results and a statistical comparison of change are not reported in the registry record, so the relative outcome cannot be determined from the record described.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group trial of two app-based conditions. Participants were assigned to WisePath for Adults or to an active control consisting of a suicide-prevention self-help app plus an electronic wellness-resources brochure. An active control provides resources rather than an absence of intervention; therefore, the intended comparison is between these two packages, not between WisePath and no support.
The brief summary describes an intended 12-week trial and says participants would be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks. The record lists enrollment as 127, while the summary describes a plan for 120 participants, with 60 assigned to each condition. These are distinct registry statements; the record does not explain their relationship or report the analyzed group sizes for each assessment.
The listed start date is 2025-03-05, the primary completion date is 2025-11-10, and the status is completed. The phase is listed as NA. The record describes the study as an intent-to-treat randomized controlled trial, but the population field for the primary outcome notes that the number analyzed differs across rows because of attrition over different timepoints. The exact analysis population for each result is not reported in the registry record.
The registry lists one secondary outcome, an App Satisfaction Survey, and reports eight outcome measures overall. It lists zero analyses. A detailed account of allocation concealment, masking procedures, adherence monitoring, treatment exposure, or follow-up procedures is not reported in the registry record. Randomization and double masking are recorded design labels, but they do not by themselves establish how those procedures were implemented.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 401 individuals completed the initial screen. Of the 176 eligible, 45 were lost to follow-up, and 4 declined to participate before completing the informed consent. 127 participants completed consent and were randomized to a condition.
Overall Study
| Stage | WisePath for Adults | Active-Control App + Electronic Wellness Resources Brochure |
|---|---|---|
| STARTED | 64 | 63 |
| COMPLETED | 61 | 61 |
| NOT COMPLETED | 3 | 2 |
Analysis population for the primary outcome, as defined in the registry: The number analyzed differs between rows because of attrition over different timepoints.
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 participants completed Baseline (Time 1).
| Characteristic | Unit | WisePath for Adults | Active-Control App + Electronic Wellness Resources Brochure | Total |
|---|---|---|---|---|
| Participants analysed | 64 | 63 | 127 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 64 | 60 | 124 |
| Age, Categorical: >=65 years | Participants | 0 | 3 | 3 |
| Sex/Gender, Customized: Female | Participants | 34 | 37 | 71 |
| Sex/Gender, Customized: Male | Participants | 27 | 25 | 52 |
| Sex/Gender, Customized: Nonbinary | Participants | 3 | 1 | 4 |
| Race/Ethnicity, Customized: White | Participants | 32 | 35 | 67 |
| Race/Ethnicity, Customized: Black | Participants | 22 | 19 | 41 |
| Race/Ethnicity, Customized: Asian or Asian American | Participants | 9 | 7 | 16 |
| Race/Ethnicity, Customized: American Indian or Alaskan Native | Participants | 7 | 4 | 11 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Other | Participants | 6 | 7 | 13 |
| Region of Enrollment: United States | Participants | 64 | 63 | 127 |
| Hispanic/Latinx: Hispanic/Latinx | Participants | 13 | 13 | 26 |
| Hispanic/Latinx: Not Hispanic/Latinx | Participants | 51 | 50 | 101 |
| Mental Health Treatment: Not engaged in mental health treatment | Participants | 33 | 33 | 66 |
| Mental Health Treatment: 2 or less hours a week | Participants | 30 | 29 | 59 |
| Mental Health Treatment: 3 or more hours a week | Participants | 1 | 1 | 2 |
| Employment: Employed | Participants | 50 | 46 | 96 |
| Employment: Unemployed | Participants | 14 | 17 | 31 |
| Lifetime Suicide Attempts: None | Participants | 40 | 38 | 78 |
| Lifetime Suicide Attempts: 1-2 | Participants | 10 | 11 | 21 |
| Lifetime Suicide Attempts: 3 or more | Participants | 14 | 14 | 28 |
| Technology Usage: Minimum Use | Participants | 0 | 0 | 0 |
| Technology Usage: Medium Use | Participants | 2 | 1 | 3 |
| Technology Usage: High Use | Participants | 62 | 62 | 124 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Self-Injurious Thoughts and Behaviors Interview-Revised, measured over Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is change in the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI) from baseline to follow-up assessments scheduled at 4 weeks, 8 weeks, and 12 weeks. The registry describes the SITBI as a structured interview that can also be delivered as self-report. Its modules assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self-injury.
The endpoint is intended to capture several dimensions of self-injurious thoughts and behaviors rather than a single event alone. The registry description specifically says peak suicidal ideation intensity, suicide plan forecasting, and suicide attempt forecasting are scored on a 5-point scale, from 0, described as low or little, to 4, described as very much or severe. Higher scores indicate greater intensity of suicidal ideation and greater likelihood of making a suicide plan or attempt. The record does not clarify which SITBI components contribute to the reported primary score or how a combined score would be formed.
Repeated assessment can describe how scores vary over follow-up, while the same instrument in both randomized groups allows a comparison of their observed trajectories. General statistical context: repeated measures can provide information about change over time, but interpretation depends on clearly defined scoring, the handling of missing observations, and a specified comparison between groups. Numerical scores, variability estimates, and group comparisons are not reported in the registry record, so the direction, magnitude, and precision of any observed change cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a repeated-measures primary outcome, but it does not report numerical results for that outcome. In particular, it does not provide the group means, standard deviations, changes from baseline, between-group contrasts, confidence intervals, or p-values for the SITBI. Without these statistics, the outcome cannot be described as favoring either condition, and neither the size nor the precision of a possible difference can be evaluated.
The listed primary outcome concerns change at multiple follow-up times, rather than one isolated endpoint. To interpret such results, a reader would need to know whether the analysis compared changes between groups at each time, modeled the full trajectory, or used another prespecified contrast. The registry record does not report the primary statistical comparison or its model. It also does not state whether adjustment was made for baseline score or other variables. These details matter because different analyses can target different quantities and yield different uncertainty estimates.
The record notes that the number analyzed differs across outcome rows because of attrition over time. That is important context: a result based on participants with observed assessments may represent a different set of people at each follow-up. The record does not give the number analyzed at each timepoint, the reasons for missing assessments, or the method used to address missing data. The intent-to-treat description indicates an intended analysis principle, but the record does not provide enough detail to establish how it was implemented.
The record also reports adverse-event counts, including zero serious adverse events affecting participants and zero deaths in both listed groups. These entries should be read as registry-reported counts for the populations indicated there, not as proof that no adverse event of any kind occurred. Other adverse events are also listed, and a registry count alone does not describe their nature, timing, severity, or relationship to an app.
The registry lists sample-size planning illustrations based on fractions of an observed effect. Such illustrations are prospective calculations under stated assumptions, not observed evidence about the treatment contrast and not a measure of the study's achieved power. They cannot substitute for the missing outcome estimates and uncertainty intervals. The record does not report the study's own sample-size justification or a statistical analysis plan.
Overall, the available registry information supports a description of the study question, design, scheduled assessments, and selected safety counts. It does not support a conclusion about the comparative primary outcome. A careful interpretation should distinguish the existence of a randomized design from the availability of outcome evidence: randomization can help make a comparison interpretable, but the numerical results and analysis details are needed to assess what the comparison found.
9. Statistical Methods Explained
What does randomization contribute?
Random assignment is intended to make the intervention groups comparable, on average, with respect to measured and unmeasured characteristics at the time of assignment. This helps limit confounding when comparing outcomes. It does not ensure that the groups will be identical in a particular trial, and it does not prevent later differences in retention, adherence, or outcome measurement. The registry identifies the allocation as randomized but does not report the sequence-generation or concealment procedures.
What does double masking mean?
The record labels the trial double-masked. Masking is intended to reduce bias that can arise when knowledge of assigned condition influences care, behavior, outcome reporting, or assessment. For app-based interventions, the practical meaning of masking depends on which people were unaware of assignment and how the two conditions were presented. Those implementation details are not reported in the registry record. The label alone does not establish that participants, assessors, or analysts were all masked.
Why use an active control?
The comparison condition includes a self-help app and an electronic wellness-resources brochure. Because that condition has content of its own, the contrast estimates the difference between the WisePath package and the active-control package, as implemented in the trial. It does not estimate the effect of receiving an app compared with receiving nothing. General statistical context: the more closely the control matches the intervention in attention, access, and engagement, the more the contrast may focus on differences in their content, but matching and engagement details are not reported in the registry record.
How should a continuous score be read?
The primary outcome is classified as continuous and summarized using a mean and standard deviation. A mean describes the average score in the analyzed group; a standard deviation describes how spread out individual scores are around that mean. Neither statistic alone gives the treatment contrast. A comparison requires an estimate of how the groups differ, often with an uncertainty interval. The record describes higher scores as indicating greater intensity or likelihood for the specified SITBI domains, but does not provide numerical outcome summaries.
What does a confidence interval communicate?
General explanation: a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance. An interval that includes values corresponding to little or no difference can leave substantial uncertainty about the direction or size of a contrast. The registry record does not report a confidence interval for the primary outcome, so its precision cannot be judged.
Why do repeated measurements need an analysis strategy?
Scores are scheduled at baseline and several follow-up times. Measurements from the same participant are related, so they should not automatically be treated as independent observations. General statistical context: repeated-measures approaches can account for within-person association and use the pattern of observations over time. The precise approach depends on the target question, assumptions about the outcome and missingness, and the model specification. The registry record does not report whether the analysis used a repeated-measures model, separate timepoint comparisons, or another method.
A time-by-group comparison asks whether the groups' outcome patterns differ over follow-up. Separate comparisons at each follow-up instead ask about particular timepoints and may create multiple opportunities for an apparently notable result. A single prespecified primary contrast can make the target of inference clearer. Which contrast was intended, how baseline was handled, and whether any multiplicity adjustment was planned are not reported in the registry record.
Why does over-dispersion matter?
General explanation: over-dispersion occurs when the observed variability in data is greater than a statistical model assumes. It is especially relevant to count outcomes, where a simple model may assume a particular relationship between the mean and variance. If that assumption is too restrictive, standard errors can be too small and uncertainty can be understated. The listed primary endpoint is a continuous score summarized by mean and standard deviation, not a count endpoint. The record does not report a model or diagnostic results indicating whether over-dispersion was assessed for any other outcome.
How do planning illustrations differ from trial results?
The registry's sample-size assumptions describe illustrations based on fractions of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. For non-time-to-event outcomes, those calculations are framed as participants per arm for 80% or 90% power; time-to-event calculations are described as total event counts. These are planning illustrations, not observed group outcomes, and not observed power. The record does not report the trial's own sample-size justification or show that these assumptions were part of the original design. A planning calculation cannot establish that an effect was found or that a result is precise.
Any recalculation from posted summary statistics would be an unadjusted calculation, distinct from the sponsor's analysis. If a discrepancy is identified between such a calculation and the sponsor's analysis, the sponsor's own analysis takes precedence. The registry record described does not include primary-outcome summaries or analyses from which a recalculation could be interpreted.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, timepoints, or contrasts are tested. The registry describes the primary outcome at baseline, 4 weeks, 8 weeks, and 12 weeks, and lists eight outcome measures overall. It also lists an App Satisfaction Survey as a secondary outcome. The record does not report which comparisons were designated as primary within the repeated assessments, whether a hierarchy of outcomes was specified, or whether any adjustment for multiple testing was planned. Without those details, the risk of interpreting one result among many as definitive cannot be evaluated.
Missing data are a particular consideration because the primary outcome population note says that the number analyzed differs between rows due to attrition over time. The registry does not report the number observed at each assessment, the extent or reasons for loss to follow-up, or whether missingness differed between randomized groups. It also does not report whether missing scores were handled through a model, imputation, a complete-case approach, or another method. General statistical context: conclusions can depend on whether people with missing outcomes differ systematically from those with observed outcomes and on the assumptions used to address that difference.
The brief summary uses the term intent-to-treat, but the registry record does not explain the analysis population or implementation sufficiently to determine how all randomized participants were handled. It does not report a per-protocol or other analysis population either. The record lists zero analyses, and no numerical primary-outcome analysis is available in the information described. Thus, neither multiplicity control nor the robustness of findings to missing-data assumptions can be assessed.
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 |
|---|---|---|---|
| WisePath for Adults | 0 | 64 | 0.0% |
| Active-Control App + Electronic Wellness Resources Brochure | 0 | 63 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| WisePath for Adults | 0 of 64 |
| Active-Control App + Electronic Wellness Resources Brochure | 0 of 63 |
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 |
|---|---|
| WisePath for Adults | 36 of 64 |
| Active-Control App + Electronic Wellness Resources Brochure | 35 of 63 |
Most frequent serious adverse event terms
| Event term | Organ system | WisePath for Adults | Active-Control App + Electronic Wellness Resources Brochure |
|---|---|---|---|
| Suicide attempt that leads to acute hospital-based care | Psychiatric disorders | 0 of 64 | 0 of 63 |
| Alcohol poisoning that leads to acute hospital-based care | Psychiatric disorders | 0 of 64 | 0 of 63 |
Most frequent non-serious adverse event terms
| Event term | Organ system | WisePath for Adults | Active-Control App + Electronic Wellness Resources Brochure |
|---|---|---|---|
| Significant increase in suicidal ideation frequency | Psychiatric disorders | 16 of 64 | 14 of 63 |
| Self-report of blackouts related to alcohol use | Psychiatric disorders | 13 of 64 | 10 of 63 |
| Significant increase in alcohol use | Psychiatric disorders | 9 of 64 | 10 of 63 |
| Significant increase in negative consequences related to alcohol use | Psychiatric disorders | 9 of 64 | 8 of 63 |
| Significant increase in suicidal ideation intensity | Psychiatric disorders | 7 of 64 | 7 of 63 |
| Self-report of injuries to themselves or others related to alcohol use | Psychiatric disorders | 4 of 64 | 3 of 63 |
| Warm Handoff to 988 | Psychiatric disorders | 3 of 64 | 1 of 63 |
| Suicide attempts that do not require medical attention or hospital-based care | Psychiatric disorders | 0 of 64 | 1 of 63 |
| Suicide attempt that leads to acute hospital-based care (e.g., ED visit) | Psychiatric disorders | 0 of 64 | 0 of 63 |
Serious events with the highest arm-level rate: suicide attempt that leads to acute hospital-based care (0.0%), alcohol poisoning that leads to acute hospital-based care (0.0%).
The registry reports zero serious adverse events affecting participants and zero deaths in each of the two listed groups. It lists 64 participants at risk for serious adverse events in the WisePath group and 63 in the active-control group. The registry also lists other adverse events affecting 36 in the WisePath group and 35 in the active-control group, with 64 and 63, respectively, shown as at risk. These are registry entries and should not be conflated with the primary effectiveness outcome.
The serious adverse event terms listed are a suicide attempt that leads to acute hospital-based care and alcohol poisoning that leads to acute hospital-based care; each is reported as 0.0%. The record does not describe the time period or event-level context for these terms beyond the safety information listed. It also does not provide details about the types, severity, timing, or relatedness of the other adverse events. The at-risk counts are the registry's stated denominators for these safety summaries and should not be replaced with the planned enrollment figures.
A zero count in a registry report means that no event was recorded in the listed category for the reported group and record. It does not establish that the intervention has no risk, nor does it describe every possible adverse event or establish comparative safety. Rare events and incomplete reporting can limit what can be inferred from observed counts. The safety entries should therefore be read narrowly, alongside the absence of detailed event descriptions in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare WisePath for Adults with an active-control app and electronic wellness-resources brochure in adults described as suicidal, with possible alcohol misuse. It identifies randomization, double masking, parallel groups, and a primary outcome focused on changes in SITBI scores across scheduled assessments. Those features define the intended comparison, but they do not reveal its result.
No numerical primary-outcome results are reported in the information described. It is therefore not possible to state whether scores changed in either group, whether the groups differed, how large any difference was, or how precisely it was estimated. The absence of reported results in the registry record is not evidence that there was no effect or that the groups had identical outcomes. It means the comparative finding cannot be evaluated from this record.
The active control also shapes what the trial could answer. A comparison between the two app-based packages concerns their relative outcomes under the study conditions; it is not a direct comparison against no app or no resources. The record does not report app use, engagement, or adherence, so it is not possible to judge whether differences in exposure could help explain any eventual outcome pattern.
The registry's safety entries report zero serious adverse events affecting participants and zero deaths in both groups, while also listing other adverse events. These records do not provide a complete account of event types or establish that either package is free of risk. Similarly, the planning illustrations are not trial findings and cannot resolve uncertainty about the actual outcome contrast.
A fuller assessment would require the numerical outcome summaries, a clearly defined between-group estimand, an uncertainty interval, and details of how repeated observations and attrition were handled. Without these, the record supports a description of the research question and design, but not a conclusion about comparative effectiveness, precision, or robustness.
13. Why This Trial Matters Statistically
This trial is statistically notable for asking a longitudinal question in a randomized setting. Rather than focusing only on a single assessment, the registry describes repeated SITBI measurement from baseline through 12 weeks. A longitudinal design can characterize changes over time, but its interpretation depends on a clearly specified group comparison and appropriate handling of repeated measurements from the same participant. Those analysis details are not reported in the registry record.
The comparator is active: it combines an app with educational and wellness resources. This makes the comparison relevant to the relative outcomes of two resource packages, while limiting any interpretation to that contrast. It would be incorrect to read the design as estimating the effect of app support against no support. The record's description of both conditions helps define that distinction, even though intervention exposure and engagement are not reported.
Attrition is statistically important because the registry notes that the number analyzed differs across primary-outcome rows. Changing observed participant counts across time can affect the population represented by each estimate and the precision of longitudinal comparisons. Clear reporting of follow-up, missingness, and analysis assumptions is needed to judge whether a result is robust.
The record also illustrates why registry design information and outcome evidence must be kept separate. Randomization, masking labels, scheduled timepoints, and sample-size planning assumptions describe how a study is intended to operate or be analyzed. They are not themselves evidence of an outcome difference. Because numerical primary results are not reported in the registry record, the statistical question remains unresolved in the information described.
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 limitation for interpretation is the absence of numerical primary-outcome results. The registry identifies the SITBI and assessment schedule but does not report group means, standard deviations, changes, between-group estimates, confidence intervals, or p-values. The record also does not clarify the precise score used as the primary endpoint or which components of the measure contribute to it.
The registry gives different enrollment descriptions: enrollment is listed as 127, while the study summary describes a planned 120 participants with 60 assigned to each condition. The record does not explain this difference or provide analyzed group sizes at the individual timepoints. It does note attrition over time, but detailed retention information and reasons for missing data are not reported.
Although the study is labeled randomized and double-masked, procedures for sequence generation, allocation concealment, and masking implementation are not reported. The record does not report adherence, app use, intervention fidelity, or whether participants accessed other services. These details would help characterize how the assigned conditions were experienced, but cannot be inferred from the intervention labels.
The registry lists eight outcome measures but does not provide the analysis details needed to assess outcome selection, multiplicity, or the primary contrast. The statistical model, handling of baseline measurements, missing-data approach, and any planned sensitivity analyses are not reported in the registry record. The listed sample-size assumptions are planning illustrations and do not substitute for the study's own sample-size rationale, which is not reported.
Safety information is limited to event counts and selected serious-event terms. The nature and timing of other adverse events, as well as their relationship to the study conditions, are not reported. These limitations restrict interpretation of both outcomes and safety to the descriptions and counts entered in the registry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Drivers of Suicide Mobile App Study — NCT05427734.
- Registry record last updated 2026-04-17; status last verified 2026-04.
- Results first posted 2026-04-17.
- 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 describes NCT05427734, the Drivers of Suicide Mobile App Study, as a completed, randomized, double-masked, parallel-group trial. It compares WisePath for Adults with an active-control suicide-prevention app plus an electronic wellness-resources brochure. The record lists enrollment as 127; the brief summary describes a planned 12-week study with 120 suicidal adults 22 years and older, assigned as 60 per condition.
The primary outcome is change in SITBI scores, assessed at baseline, 4 weeks, 8 weeks, and 12 weeks. The registry notes that analyzed numbers differ across rows because of attrition. It does not report numerical primary-outcome results or the statistical analysis used. Safety entries list zero serious adverse events affecting participants and zero deaths in each group, alongside other adverse-event counts. The record lists the study status as completed, but the comparative outcome and its precision cannot be assessed from the registry information described.