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 Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms (NCT00565136), a na phase 1, phase 2 study. The primary outcome is Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00565136 |
| Phase | Phase 1, Phase 2 |
| Condition | Fecal Incontinence |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ASTORA Women's Health |
| Results posted | Yes |
2. Clinical Question
Population
Women with moderate fecal incontinence symptoms. The registry record lists 29 participants enrolled. The bowel-diary population varied by visit: Baseline N=29, 6 Week N=26, 3 Month N=27, 6 Month N=24, 12 Month N=23, and 24 Month N=26.
Intervention
TOPAS, described as the AMS Pelvic Floor Repair System and a minimally invasively delivered self-fixating mesh intended to restore pelvic floor support.
Comparator
There was no separate comparator group. The study is listed as single group, with allocation recorded as NA. Baseline and follow-up observations are part of the same group, not a randomized control comparison.
Primary question
How did the mean number of fecal incontinence episodes, including solid and liquid stools, measured by subject-reported bowel diary change from baseline through follow-up? The 3 Month post-treatment visit was the primary endpoint time period.
The question is descriptive and within-group: the registry record specifies repeated measurements after treatment, rather than a comparison between participants assigned to different interventions. Such a design can describe bowel-diary measures at the stated visits, but by itself it cannot distinguish changes associated with treatment from changes that might occur for other reasons over time.
The record also lists secondary outcomes covering complications, fecal incontinence symptoms, quality of life, pain intensity, and surgical parameters. Numerical results for these outcomes are not reported in the registry record. The stated study purpose was to gain experience with the TOPAS system in women with moderate fecal incontinence symptoms; the record does not report a comparative efficacy question or a control treatment.
3. Trial Design
This completed study is registered as a Phase 1 and Phase 2, single-group device study sponsored by ASTORA Women's Health. Enrollment was 29. The registry lists a start of 2007-09 and primary completion of 2010-12. The intervention was TOPAS, identified in the arm description as the TOPAS AMS Pelvic Floor Repair System. The brief description characterizes it as a minimally invasively delivered self-fixating mesh for treatment of pelvic floor weakness in women with moderate fecal incontinence symptoms.
The study has no parallel control arm in the registry record. Allocation is listed as NA, and masking is listed as NONE. These entries mean that the design should not be read as a randomized, blinded comparison. Instead, the primary outcome is described at baseline and at post-treatment visits in the same study group. The record does not report a protocol detail explaining allocation beyond the single-group designation.
The primary outcome was fecal incontinence incidence from baseline through 24 months post-treatment, measured as the mean number of fecal incontinence episodes per 14 day period. The outcome includes solid and liquid stools and is based on a subject-reported bowel diary. Visits are specified at Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month, and 24 Month post-treatment. The 3 Month post-treatment visit was the primary endpoint time period.
The record lists secondary outcomes for complications during the 24 Month post-treatment follow-up period; Wexner Score; Symptom Severity Scale in Fecal Incontinence; Fecal Incontinence Quality of Life; Pain Intensity Scale; procedure length; hospital stay; and estimated blood loss during implantation. The record reports 15 outcome measures but 0 analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record. The statistical analysis plan, sample-size justification, interim analyses, and detailed analysis populations are not reported in the registry record.
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: After signing informed consent and prior to implant, subjects completed a 3-week bowel diary to describe the FI episodes, Fecal Incontinence Quality of Life scale, Wexner Score, Symptom Severity Scale in Fecal Incontinence, pain intensity scale, and dynamic MRI or defecography.
Overall Study
| Stage | TOPAS |
|---|---|
| STARTED | 29 |
| COMPLETED | 26 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | TOPAS |
|---|---|
| Lost to Follow-up | 1 |
| Withdrawal by Subject | 1 |
| Protocol Violation | 1 |
Analysis population for the primary outcome, as defined in the registry: The FI Bowel Diary was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26
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: 20-30 subjects were targeted for enrollment. There was no sample size and power analysis performed for this study.
| Characteristic | Unit | TOPAS |
|---|---|---|
| Participants analysed | 29 | |
| Age, Continuous | years | 60.6 (SD 13.9) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 0 |
| Race/Ethnicity, Customized: White / Caucasian | participants | 28 |
| Race/Ethnicity, Customized: Other | participants | 1 |
| Height | cm | 164.8 (SD 5.9) |
| Weight | kg | 76.3 (SD 19.6) |
| Body Mass Index | kg/[m]^2 | 28.1 (SD 7.1) |
| Gravidity | pregnancies | 3.6 (SD 2.1) |
| Parity | births | 2.9 (SD 1.1) |
| Number Cesarean Births | deliveries | 0.1 (SD 0.3) |
| Number of Vaginal Births | deliveries | 2.8 (SD 1.1) |
| Menopausal Status: Pre-menopausal | participants | 7 |
| Menopausal Status: Post-menopausal | participants | 22 |
| Fecal Incontinence Treatment History (failed modalities): Diet modification | participants | 25 |
| Fecal Incontinence Treatment History (failed modalities): FI medication | participants | 9 |
| Fecal Incontinence Treatment History (failed modalities): Biofeedback | participants | 11 |
| Fecal Incontinence Treatment History (failed modalities): Pelvic surgery | participants | 3 |
| Fecal Incontinence Treatment History (failed modalities): Other | participants | 6 |
| Etiology of Fecal Incontinence: Neurological | participants | 2 |
| Etiology of Fecal Incontinence: Anorectal trauma | participants | 4 |
| Etiology of Fecal Incontinence: Obstetric trauma | participants | 10 |
| Etiology of Fecal Incontinence: Idiopathic/Unknown | participants | 15 |
| Etiology of Fecal Incontinence: Congenital abnormality | participants | 0 |
| Etiology of Fecal Incontinence: Other | participants | 0 |
| Colonoscopy within past 10 years: Yes | participants | 24 |
| Colonoscopy within past 10 years: No | participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment, measured over Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Number of FI episodes/14 day period |
| Endpoint classification | Continuous Endpoint |
The primary endpoint counts fecal incontinence episodes recorded in a subject-reported bowel diary. Its unit is the number of episodes per 14 day period, and the summary measure is the mean. Solid and liquid stools are included. The scheduled observations are at baseline and at 6 Week, 3 Month, 6 Month, 12 Month, and 24 Month post-treatment; the 3 Month visit is identified as the primary endpoint time period.
As a continuous measure, an average can describe the overall episode frequency in the observed group, while the standard deviation describes how spread out individual measurements are around that average. General statistical interpretation: the mean is useful for summarizing a numeric outcome across participants, but it does not show the full shape of the data or whether a small number of participants had especially high or low counts. A diary-based measure can capture repeated events in everyday life, while its interpretation depends on completing the diary and recording events consistently.
The endpoint gives a specified way to summarize symptoms over a fixed diary period and to describe how group values vary over scheduled visits. It is not itself a comparison against an untreated or alternative-treatment group. Numerical means and standard deviations at the visits, and numerical estimates of change, are not reported in the registry record. Reasons for the visit-specific diary counts and any rules for handling incomplete diaries are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the design, endpoint definition, visit schedule, and numbers of participants completing a bowel diary at each visit. It does not report the primary endpoint's numerical mean or standard deviation at baseline or follow-up. Consequently, the direction and magnitude of any change in diary-recorded fecal incontinence episodes cannot be described from the registry record. The record also does not report a numerical treatment-effect estimate or a confidence interval for the primary endpoint.
The stated primary time point is 3 Month post-treatment. The bowel diary was completed by N=27 at that visit, compared with N=29 at Baseline. Counts at the other visits were N=26 at 6 Week, N=24 at 6 Month, N=23 at 12 Month, and N=26 at 24 Month. These visit-specific counts show that the number contributing diary data was not identical across visits. The reasons for those differences, and whether any analysis accounted for them, are not reported in the registry record.
Because the design is single group and unmasked, a within-group change, if one were reported, would not constitute a randomized treatment-versus-control effect. General statistical interpretation: a before-and-after pattern can be influenced by factors other than the intervention, including natural variation over time, expectations, and differences in who contributes data at each visit. Without a concurrent comparator, the study does not separate those possibilities from an intervention-associated change.
The record lists 15 outcome measures and 0 analyses. It names several secondary measures but does not report their numerical results. Thus, statements about complications, symptom scores, quality of life, pain, or surgical parameters beyond the posted adverse-event counts would exceed what the registry record reports. No multiplicity procedure is described, and the statistical plan is not reported in the registry record.
The safety information is a separate descriptive component. The registry lists 5 participants at risk and affected for serious adverse events, with 29 at risk, and lists 22 participants affected for other adverse events, with 29 at risk. It also lists serious adverse-event terms with percentages. These figures should be read as registry-reported safety counts and terms, not as a comparison with another treatment. The record does not report a control-group rate or enough detail to infer comparative risk.
Overall, the record allows readers to identify what the study intended to measure and the amount of diary participation recorded at each visit. It does not supply the primary outcome values needed to judge the observed symptom pattern or its precision. The study description and the posted safety information should therefore be distinguished from evidence of a comparative effect, which this single-group design and these posted data do not establish.
9. Statistical Methods Explained
The registry defines the primary outcome as a mean, a measure suited to a numeric variable. For this study, the variable is the number of fecal incontinence episodes recorded per 14 day period. The mean summarizes the group’s diary counts at a visit. The standard deviation, also specified in the registry, describes variation among the recorded values around their mean. General statistical explanation: the mean and standard deviation together give a compact description, but they do not reveal every feature of the distribution. Episode counts can vary between participants, and the summary alone does not show whether the distribution is symmetric or whether some participants have unusually high counts.
What does a repeated-visit measure describe?
Diary observations were scheduled at baseline and across post-treatment visits through 24 Month. Comparing the group’s mean at those times would describe the pattern of observed diary counts over follow-up. A change in a group mean is not automatically a causal effect. General statistical explanation: causal attribution is stronger when a comparison group represents what would have happened over the same period without the intervention, because both groups can then be considered in relation to shared changes over time. No separate control group is listed for this study.
The specified primary endpoint is the 3 Month post-treatment visit. Identifying one primary time point can focus interpretation on a prespecified question, but the registry record does not report the analysis plan or how that primary time point was handled statistically. It also does not report whether the primary analysis compared the 3 Month mean with baseline, estimated change for each participant, or used another model. Those details are not reported in the registry record and should not be inferred from the endpoint description alone.
Why do the visit-specific counts matter?
The bowel-diary counts are N=29 at Baseline, N=26 at 6 Week, N=27 at 3 Month, N=24 at 6 Month, N=23 at 12 Month, and N=26 at 24 Month. A mean at each visit describes the participants contributing data at that visit. If the participants differ across visits, the sequence of means may reflect both changes over time and changes in who contributed a diary. General statistical explanation: missing observations can affect estimates when the likelihood of missingness is related to outcome values or participant characteristics. The registry record does not state why the visit counts differ, whether diaries were incomplete, or how missing observations were handled.
A confidence interval, in general, is a range of values reflecting uncertainty around an estimate under the assumptions of the analysis. It helps distinguish a relatively precise estimate from one with substantial uncertainty. The registry record does not report a confidence interval for the primary outcome, so the precision of any primary endpoint estimate cannot be assessed from the posted record. A standard deviation is not a substitute for a confidence interval: the former describes participant-level spread, while the latter describes uncertainty in an estimated quantity.
What would a comparison add?
General statistical explanation: a randomized comparison can balance measured and unmeasured characteristics on average, supporting a more direct estimate of differences between assigned groups. This trial is listed as single group, with allocation NA and masking NONE, so it offers no randomized treatment contrast. Baseline measurements can provide context for later observations but do not replace an independent control group. Any change over time would remain vulnerable to explanations that cannot be separated using the design alone.
There are 15 outcome measures listed and 0 analyses. When many outcomes or time points are considered, the chance of finding an apparently notable result by chance can increase if each is tested separately. General statistical explanation: multiplicity methods can control or describe this issue, for example by adjusting inference or defining a hierarchy of outcomes. The registry record does not report a multiplicity strategy, a testing hierarchy beyond identifying the primary endpoint period, or a statistical analysis plan. No claim about adjustment should be made.
How should planning illustrations be understood?
General statistical explanation: a sample-size calculation estimates how many participants would be needed under specified assumptions to detect a chosen effect with a chosen error rate and power. The planning assumptions described for the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the stated approach uses a total number of events; for other outcomes, it gives participants per arm. Those are hypothetical planning conventions, not the design of this single-group study. The registry record does not report the study’s own sample-size justification. Such illustrations are not observed power and do not establish that a study was adequately powered.
The record does not report the test or model used for the primary endpoint, adjustments for baseline values, handling of repeated observations, assumptions about the distribution of episode counts, or diagnostic checks. General statistical explanation: if outcome variability exceeds what a model assumes, uncertainty estimates and tests may be unreliable; methods that account for extra variability may then be considered. Whether such over-dispersion was present or addressed in this trial is not reported in the registry record. No recalculated result should be treated as the sponsor’s analysis if the posted analysis differs; any discrepancy would give precedence to the sponsor’s own analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures, including the primary diary endpoint and secondary measures covering complications, symptom scales, quality of life, pain, and surgical parameters. The primary time point is identified as 3 Month post-treatment. However, the registry record does not report a statistical analysis plan, a hierarchy for testing outcomes, or a multiplicity adjustment. General statistical explanation: when investigators examine many outcomes or time points, interpreting each nominal test as if it were the only test can make chance findings more likely. Without a reported strategy, readers cannot determine how the study intended to manage that issue.
The record reports 0 analyses and does not include numerical results for the primary endpoint. It also does not state which analysis population was intended, such as all enrolled participants or a defined subset, or whether participants were included only when they completed particular visits. The number with diary data varies by visit: Baseline N=29, 6 Week N=26, 3 Month N=27, 6 Month N=24, 12 Month N=23, and 24 Month N=26. The record does not explain the differences or describe a missing-data method.
General statistical explanation: missing-data handling matters because results can be biased if the probability of observing an outcome is related to the unobserved outcome or participant characteristics. Complete-case summaries, imputation, or repeated-measures models rely on different assumptions; the registry record does not identify which, if any, was used. It also does not report sensitivity analyses assessing the effect of missing observations. Therefore, the impact of incomplete follow-up on the outcome estimates cannot be assessed from the 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 |
|---|---|---|---|
| TOPAS | 5 | 29 | 17.2% |
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 |
|---|---|
| TOPAS | 22 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | TOPAS |
|---|---|---|
| Low Back Pain/Disk Herniation | Nervous system disorders | 1 of 29 |
| Blood Clot in Lungs | Respiratory, thoracic and mediastinal disorders | 1 of 29 |
| Right Leg Cellulitis | Infections and infestations | 1 of 29 |
| Costochondoritis | Musculoskeletal and connective tissue disorders | 1 of 29 |
| Carpel Tunnel | Musculoskeletal and connective tissue disorders | 1 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TOPAS |
|---|---|---|
| Other (unclassified) | Investigations | 13 of 29 |
| Urinary Incontinence (De Novo) | Renal and urinary disorders | 5 of 29 |
| Urinary Tract Infection | Renal and urinary disorders | 4 of 29 |
| Dyspareunia (De Novo) | Reproductive system and breast disorders | 3 of 29 |
| Worsening Fecal Incontinence | Gastrointestinal disorders | 3 of 29 |
| Infection (other than urinary tract infection) | Infections and infestations | 3 of 29 |
| Worsening Vaginal Prolapse | Reproductive system and breast disorders | 2 of 29 |
| Worsening Urinary Incontinence | Renal and urinary disorders | 2 of 29 |
| Leg Pain | Musculoskeletal and connective tissue disorders | 2 of 29 |
| Worsening Depression | Psychiatric disorders | 2 of 29 |
Serious events with the highest arm-level rate: low back pain/disk herniation (3.4%), blood clot in lungs (3.4%), right leg cellulitis (3.4%), costochondoritis (3.4%), carpel tunnel (3.4%).
The registry lists 29 participants at risk for serious adverse events and 5 affected. It separately lists 29 at risk for other adverse events and 22 affected. These are descriptive counts within the TOPAS group, not comparisons with a control group. The record lists the following serious adverse-event terms, each with a reported frequency of 3.4%: Low Back Pain/Disk Herniation, Blood Clot in Lungs, Right Leg Cellulitis, Costochondoritis, and Carpel Tunnel.
Those terms and percentages describe the entries in the registry. They do not establish that the device caused an event, and the record does not report event relatedness or a comparative rate. The terms should not be added together to infer a total number of affected participants, because the record does not state whether participants could appear under more than one term. The deaths entry is not reported in the registry record. Further details on event timing, severity grading, or outcomes are not reported in the registry record.
General statistical explanation: safety counts in a small, uncontrolled group can identify events recorded during follow-up, but they cannot by themselves estimate excess risk relative to another treatment or background rate. The listed at-risk counts provide the group denominators used in the registry entry; they do not resolve the limitations of a noncomparative design.
12. What the Result Does, and Does Not, Mean
The record describes a study of TOPAS in women with moderate fecal incontinence symptoms and specifies a bowel-diary endpoint measured from baseline through 24 Month post-treatment. The primary endpoint focused on the 3 Month visit and counted episodes of solid and liquid stool per 14 day period. The record also documents visit-specific numbers of participants with diary data and reports descriptive safety counts and serious-event terms.
However, numerical means and standard deviations for the primary endpoint are not reported in the registry record. There is therefore no posted numerical basis for describing the size, direction, or precision of change in fecal incontinence episodes. The record also does not report numerical results for the listed secondary outcomes. A reader cannot derive an outcome estimate from the outcome definition or from the participant counts alone.
The single-group design is important to interpretation. Even if a before-and-after change were reported, it would not by itself show that the intervention caused that change, because no concurrent control group is listed. The study is unmasked, and the endpoint relies on participant-reported diaries. General statistical explanation: these design features can affect how confidently an observed pattern is attributed to an intervention, while differences in diary completion can affect which observations contribute to each visit’s summary.
The safety entries show that serious and other adverse events were recorded in the study group, with specified counts and serious-event terms. They are not a controlled comparison and do not determine whether events were caused by the device. The registry record does not report deaths, event relatedness, or comparative safety estimates. Accordingly, the record supports a description of the planned measurement and reported safety entries, but not a conclusion about comparative benefit or harm.
13. Why This Trial Matters Statistically
This study is statistically notable for the contrast between a repeated-measure clinical question and a single-group design. The primary endpoint calls for following bowel-diary episode counts from baseline across several post-treatment visits. That structure can describe the course of the measured symptom in participants with recorded diaries, but it does not provide a concurrent counterfactual. A reader must distinguish a within-group trajectory from a treatment-versus-control effect.
The endpoint is also a participant-reported count collected over a defined diary period. This makes the measurement concrete and clinically interpretable as episode frequency, while placing importance on diary completion and consistent recording. The participant counts differ by visit, and the registry record does not explain why or how the differences were addressed. This highlights a key statistical issue: outcome estimates depend not only on the measure but also on which participants contribute data at each time point.
The registry identifies a primary time point, 3 Month post-treatment, while listing a wider set of secondary outcomes. That makes the missing statistical plan especially relevant. The record does not report how repeated measurements, multiple outcomes, or incomplete data were handled. These omissions limit assessment of the inferential framework even before considering the absence of numerical endpoint results.
Finally, the safety information is reported as within-group counts and event terms. Such entries can describe what was recorded, but without a comparator they cannot quantify a relative safety difference. The study therefore illustrates why design, endpoint definition, missing-data information, and complete outcome reporting all matter alongside the headline enrollment and follow-up schedule.
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 registry record identifies a single-group study with allocation NA and masking NONE. There is no separate comparator arm, so the design cannot support a randomized between-group estimate. The enrollment was 29, and the bowel-diary population varies across visits. The record does not report why the counts vary, how incomplete diaries were handled, or whether the analysis accounted for changes in the participants contributing data.
Most importantly, numerical primary-outcome results are not reported in the registry record. The means and standard deviations needed to describe the diary endpoint at the visits are absent, as are numerical estimates of change and confidence intervals. Numerical results for the listed secondary outcomes are also not reported in the registry record, despite the record listing 15 outcome measures and 0 analyses.
The registry record does not report the statistical analysis plan, sample-size justification, interim analyses, analysis population, or multiplicity approach. It also does not report whether a model accounted for repeated observations or the distribution of episode counts. The study description therefore cannot establish what inferential methods were used or how their assumptions were assessed.
The safety record is descriptive and has no control group for comparison. Event relatedness, timing, and further clinical details are not reported in the registry record. The listed terms and percentages cannot establish causality or comparative risk. These limitations are specific to the information and design recorded for this study; they constrain what can be concluded from the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms — NCT00565136.
- Registry record last updated 2016-05-23; status last verified 2016-04.
- Results first posted 2013-08-22.
- 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
NCT00565136 is a completed Phase 1 and Phase 2, single-group device study sponsored by ASTORA Women's Health. It enrolled 29 women with moderate fecal incontinence symptoms and evaluated TOPAS, identified as the AMS Pelvic Floor Repair System. The registry lists a start of 2007-09 and primary completion of 2010-12. Allocation is NA and masking is NONE.
The primary outcome was the mean number of fecal incontinence episodes per 14 day period, including solid and liquid stools recorded in a subject-reported bowel diary. The 3 Month post-treatment visit was the primary endpoint time period. Diary counts by visit were Baseline N=29, 6 Week N=26, 3 Month N=27, 6 Month N=24, 12 Month N=23, and 24 Month N=26.
The record lists 15 outcome measures and 0 analyses. Numerical primary and secondary outcome results are not reported in the registry record. Safety entries include 5 participants affected by serious adverse events and 22 affected by other adverse events, among 29 at risk in each category.