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 Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment (NCT04078178), a randomized na study. The primary outcome is The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04078178 |
| Phase | NA |
| Condition | Cognition Disorders in Old Age, Mild Cognitive Impairment, Cognitive Decline |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Quadruple |
| Enrollment | 61 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Steven E Arnold, MD |
| Results posted | Yes |
2. Clinical Question
Population
People with subjective cognitive decline or mild cognitive impairment in aging. The primary outcome description says that participants who completed the trial were analyzed: 20 in Sequence 1 and 17 in Sequence 2.
Intervention
Niagen, a daily supplement containing a form of vitamin B3. The sequence descriptions specify 1000 mg during the Niagen period, which lasted 8 weeks.
Comparator
Placebo, taken daily for 8 weeks during the placebo period. Participants were assigned to one of two sequences, so each sequence included both Niagen and placebo periods.
Primary question
How did cognition measured with the RBANS compare between the Niagen and placebo conditions over the trial’s baseline, crossover, and end-of-study assessments? Numerical comparative results are not reported in the registry record.
This is a within-participant treatment question in a crossover design: the study planned for participants to experience both conditions, in different orders. The randomized sequences were Niagen followed by placebo, or placebo followed by Niagen. That design can support comparisons between conditions while accounting for characteristics that remain stable within a participant, but the validity of a crossover comparison also depends on how period, sequence, and possible carryover effects are handled.
The registry describes the study population as people with subjective cognitive decline or mild cognitive impairment and names cognition, mood, and daily activity in its brief summary. The listed primary outcome is narrower: objective cognitive performance measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The registry record does not report a numerical estimate of the Niagen-versus-placebo difference, its uncertainty, or a statistical test. It therefore does not establish from the posted results whether the observed scores differed between conditions or how precisely any difference was estimated.
3. Trial Design
The registry describes a randomized, quadruple-masked, placebo-controlled crossover trial. Enrollment was 61, and the record lists the study as completed. Its start date was 2020-10-30 and its primary completion date was 2022-09-30. The phase is recorded as NA.
Participants were assigned to one of two randomized block sequences. Sequence 1 received Niagen first and placebo second; Sequence 2 received placebo first and Niagen second. Each treatment period was 8 weeks, with Niagen described as 1000 mg taken daily. The primary outcome description places assessments at baseline, crossover, and the end of the study, with the overall timeframe given as baseline through the end of study at 16 weeks.
In a crossover study, each participant receives more than one study condition, and the order of conditions is part of the design. In general, this allows a comparison that uses measurements from the same participant under both conditions. It also makes period and sequence effects important: scores might change over time for reasons unrelated to treatment, and the order of conditions can matter. The registry describes the sequences but does not report how the primary analysis handled those possibilities.
The record identifies quadruple masking but does not identify which specific groups or roles were masked. It does not report a washout period between conditions. That absence should not be taken as evidence that there was or was not a washout; the detail is not reported in the registry record. The outcome description says that participants who completed the trial were analyzed, listing 20 in Sequence 1 and 17 in Sequence 2. The registry does not give a numerical primary-outcome analysis for those participants.
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: 61 Participants signed consent and enrolled in the study. Prior to randomization assignment, 15 participants screen failed. 46 proceeded to randomization assignment and study lead-in.
Lead-In Period (4-Weeks)
| Stage | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| STARTED | 23 | 23 |
| COMPLETED | 22 | 20 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| Withdrawal by Subject | 0 | 1 |
| Screen Fail | 1 | 2 |
Baseline/Initial Treatment (8 Weeks)
| Stage | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| STARTED | 22 | 20 |
| COMPLETED | 20 | 18 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| Withdrawal by Subject | 1 | 2 |
| Early Termination | 1 | 0 |
Crossover Treatment (8 Weeks)
| Stage | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| STARTED | 20 | 18 |
| COMPLETED | 20 | 17 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Sequence 1: Niagen, Then Placebo | Sequence 2: Placebo, Then Niagen |
|---|---|---|
| Early Termination | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants that completed the trial were analyzed (20 in sequence 1; 17 in sequence 2)
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 | Sequence 1: Active Niagen, Placebo | Sequence 2: Placebo, Active Niagen | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 23 | 46 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 12 | 19 |
| Age, Categorical: >=65 years | Participants | 16 | 11 | 27 |
| Sex: Female, Male: Female | Participants | 13 | 13 | 26 |
| Sex: Female, Male: Male | Participants | 10 | 10 | 20 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 | 23 | 46 |
| 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 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 20 | 17 | 37 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 4 | 7 |
| Region of Enrollment: United States | participants | 23 | 23 | 46 |
6. Primary Endpoint
The registry lists the primary outcome as The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)., measured over From baseline through end of study at 16 weeks.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is cognition measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The registry describes this as an objective measure of cognitive performance, with assessments at baseline, crossover, and the end of the study. Its stated timeframe is from baseline through the end of study at 16 weeks.
The RBANS score is reported in units on a scale. The registry describes a mean score of 100 with a standard deviation of 15, a score range from 40 to 160, and higher scores as indicating normal cognition. These are characteristics of the measure, not results from this trial. The endpoint is listed as a least-squares mean, with standard error as the dispersion measure. A least-squares mean is a model-based mean; its interpretation depends on the model and analysis details, which are not reported in the registry record.
In general, an objective standardized cognitive measure provides a defined way to assess performance rather than relying only on a participant’s impression. Repeated assessment is relevant in a crossover trial because the comparison concerns measurements over the treatment periods and their order. The registry record does not report the numerical RBANS scores, estimated condition means, difference between conditions, confidence interval, or test result. Consequently, the endpoint’s measurement properties can be described, but the magnitude and precision of the trial’s primary comparison cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies one primary outcome measure, cognition assessed with the RBANS, and specifies that the planned assessments occurred at baseline, crossover, and the end of the study. It also states that participants completing the trial were analyzed, with 20 in Sequence 1 and 17 in Sequence 2. However, the record lists zero analyses and does not report numerical results for the primary outcome. There is no posted least-squares mean for either condition, estimated treatment contrast, confidence interval, or p-value to interpret.
This means the available record does not show the size or direction of a Niagen-versus-placebo difference in RBANS scores. It also does not show how precisely that difference was estimated. Without an estimate and its uncertainty, there is no basis in the posted results for deciding whether the data are compatible with a range of possible effects or whether an apparent difference might reflect sampling variation. The absence of a reported result is not evidence that the conditions produced the same scores, nor is it evidence of a difference.
In general, a confidence interval describes uncertainty around an estimated quantity and helps readers judge which values remain compatible with the data and analysis. A p-value addresses a test under a specified statistical model and null hypothesis; it does not measure the size or practical importance of a difference. Neither is reported for the primary outcome in this registry record. No interpretation about statistical significance, clinical importance, or treatment effect can therefore be drawn from the primary endpoint entry alone.
The crossover design offers the potential to compare each participant’s experience under both conditions, but that benefit depends on the analysis matching the design. Period effects, sequence effects, and carryover are relevant general considerations because measurements are collected over time and treatment order varies. The record does not report whether these features were modeled, nor does it describe a washout period. These omissions limit assessment of the analysis, but they do not by themselves show that the trial’s design or conduct was inadequate.
The safety record lists serious and other adverse events by sequence period, including zero deaths in every listed group. Those counts describe reported events and participants at risk in the registry’s adverse-event groups. They do not supply the missing cognitive outcome results and cannot be used to infer the comparative RBANS effect. Overall, the registry record gives enough information to understand the treatment sequence and the intended primary measure, but not enough to evaluate the observed cognitive comparison.
9. Statistical Methods Explained
The study is described as randomized, quadruple-masked, placebo-controlled, and crossover. These design terms explain how the comparison was organized, but they do not reveal the details of the statistical model. The registry record does not report a statistical analysis plan or the methods used to estimate and test the primary outcome.
What does a crossover comparison involve?
In general, a crossover design exposes participants to multiple conditions in sequence. Here, one sequence received Niagen followed by placebo, while the other received placebo followed by Niagen. Because each participant contributes information under both conditions, a comparison can account for stable participant characteristics that might otherwise contribute to between-person variation. The study’s outcome assessments at baseline, crossover, and end of study are consistent with repeated measurement across the trial.
A crossover analysis must also distinguish treatment condition from time period and treatment order. In general, participants’ scores can change over time for reasons unrelated to the condition being taken. A sequence effect concerns whether the order of conditions is associated with the outcome. Carryover refers to an effect of an earlier condition persisting into a later period. These considerations do not establish that such effects occurred in this trial. The registry record does not report how they were evaluated or handled, and it does not report a washout period.
What do least-squares means and standard errors describe?
The primary outcome is specified as a least-squares mean, with standard error as its dispersion measure. In general, a least-squares mean is an estimate obtained from a statistical model, often adjusted for factors included in that model. Its meaning depends on the model’s terms and assumptions. A standard error describes the uncertainty in an estimated mean, rather than the spread of individual participants’ scores. By contrast, a standard deviation describes variation among scores. The RBANS description gives a standard deviation of 15 for the measure’s reference mean; that is not a trial-specific treatment estimate or a reported standard error.
The registry does not give the model specification, estimated least-squares means, standard errors, or a treatment contrast. It also does not provide a confidence interval or p-value for the primary outcome. The record’s description of the outcome as a least-squares mean therefore identifies the intended form of the result but does not permit reconstruction or interpretation of the trial analysis.
How should uncertainty and tests be understood?
In general, a confidence interval expresses the uncertainty around an estimate by giving a range of values compatible with the data under the specified method. A narrower interval indicates greater precision than a wider interval, but neither width nor location can be assessed without the interval itself. A hypothesis test evaluates data against a stated null hypothesis using a statistical model. A p-value is not the probability that the null hypothesis is true, and it does not describe the magnitude of an effect. No primary-outcome interval or test result is reported in the registry record.
Randomization helps make treatment assignment less dependent on participant characteristics, in expectation, but does not itself supply an estimate or ensure that all analysis assumptions are met. Masking is intended in general to reduce the influence of knowledge about condition assignment on behavior, assessment, or interpretation. The record says quadruple masking but does not identify the masked roles. The specific procedures and their success are not reported in the registry record.
What can planning calculations say?
The stated sample-size planning approach is an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes detecting a stated fraction of the observed effect. In general, planning calculations estimate the number of participants needed under chosen assumptions; they are not evidence about the uncertainty of the result actually observed. Any participant counts from such calculations are planning illustrations, not observed power. The registry record does not report the trial’s own sample-size justification.
Because the numerical primary outcome estimate is not reported in the registry record, a reader cannot evaluate what observed effect was used for planning or compare it with a clinically meaningful target. The planning assumptions should not be mistaken for the trial’s analysis plan. The record does not report interim analyses, a prespecified statistical plan, or the details needed to determine whether the primary analysis followed a particular model.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes RBANS assessments at baseline, crossover, and the end of the study. Repeated time points can create multiple possible comparisons, such as changes over time or contrasts between conditions at particular assessments. In general, making several statistical comparisons can increase the chance of finding an apparently unusual result by chance, so a prespecified analysis and any multiplicity strategy help readers understand how results were selected and interpreted. The registry record does not report a multiplicity adjustment or a plan specifying which time-point comparison was primary in the analysis.
The record lists one outcome measure and zero analyses. Its primary outcome title describes the effect of Niagen versus placebo, while the outcome description identifies multiple assessment times. Numerical estimates and tests for those assessments are not reported in the registry record. It is therefore not possible to determine which comparisons, if any, were conducted or how any multiple testing was handled.
The outcome description says that participants who completed the trial were analyzed, listing 20 in Sequence 1 and 17 in Sequence 2. It does not identify this group as an intention-to-treat population, and it does not describe an alternative analysis population. The record does not report how participants who did not complete the trial were handled, why they did not complete, whether missing measurements occurred, or how missing data were addressed. It also does not report sensitivity analyses for missing data.
These details matter because an analysis restricted to trial completers can differ from one that includes all randomized participants, and the consequences depend on why observations are missing and on the methods used. In general, missing-data assumptions cannot be verified from participant counts alone. The registry record provides the stated completer population but not the information needed to assess missingness, analysis-population choices, or robustness to those choices.
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 |
|---|---|---|---|
| Sequence 1: Baseline (Niagen) | 0 | 22 | 0.0% |
| Sequence 1: Crossover (Placebo) | 0 | 20 | 0.0% |
| Sequence 2: Baseline (Placebo) | 1 | 20 | 5.0% |
| Sequence 2: Crossover (Niagen) | 2 | 18 | 11.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sequence 1: Baseline (Niagen) | 0 of 22 |
| Sequence 1: Crossover (Placebo) | 0 of 20 |
| Sequence 2: Baseline (Placebo) | 0 of 20 |
| Sequence 2: Crossover (Niagen) | 0 of 18 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sequence 1: Baseline (Niagen) | 3 of 22 |
| Sequence 1: Crossover (Placebo) | 2 of 20 |
| Sequence 2: Baseline (Placebo) | 3 of 20 |
| Sequence 2: Crossover (Niagen) | 1 of 18 |
Most frequent serious adverse event terms
| Event term | Organ system | Sequence 1: Baseline (Niagen) | Sequence 1: Crossover (Placebo) | Sequence 2: Baseline (Placebo) | Sequence 2: Crossover (Niagen) |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | 0 of 22 | 0 of 20 | 0 of 20 | 1 of 18 |
| Fall | Musculoskeletal and connective tissue disorders | 0 of 22 | 0 of 20 | 1 of 20 | 0 of 18 |
| UTI | Renal and urinary disorders | 0 of 22 | 0 of 20 | 0 of 20 | 1 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sequence 1: Baseline (Niagen) | Sequence 1: Crossover (Placebo) | Sequence 2: Baseline (Placebo) | Sequence 2: Crossover (Niagen) |
|---|---|---|---|---|---|
| Cramping | Musculoskeletal and connective tissue disorders | 2 of 22 | 1 of 20 | 3 of 20 | 1 of 18 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 22 | 2 of 20 | 0 of 20 | 0 of 18 |
Serious events with the highest arm-level rate: dizziness (5.6%), uti (5.6%), fall (5.0%).
The registry lists adverse-event groups by sequence and period. The figures below distinguish participants at risk from participants with reported serious adverse events, other adverse events, and deaths:
- Sequence 1: Baseline (Niagen): 22 at risk; 0 with serious adverse events; 3 with other adverse events; 0 deaths.
- Sequence 1: Crossover (Placebo): 20 at risk; 0 with serious adverse events; 2 with other adverse events; 0 deaths.
- Sequence 2: Baseline (Placebo): 20 at risk; 1 with a serious adverse event; 3 with other adverse events; 0 deaths.
- Sequence 2: Crossover (Niagen): 18 at risk; 2 with serious adverse events; 1 with another adverse event; 0 deaths.
These are counts within the registry’s listed groups, not a complete comparison adjusted for exposure time or participant characteristics. The record’s top serious-event terms are Dizziness (5.6%), UTI (5.6%), and Fall (5.0%). The registry does not report the denominators or period-specific links for those percentages, so they should not be used to calculate a treatment-specific rate. The counts do not establish a causal relationship between a condition and an event. No deaths are listed in the groups.
12. What the Result Does, and Does Not, Mean
The record documents a randomized crossover study of Niagen and placebo, with cognition measured using the RBANS. It reports the assigned treatment sequences, the intended treatment periods, the measure’s scale characteristics, and the number of trial completers listed for analysis. These details help explain the question the study was designed to address.
The record does not report the numerical primary-outcome analysis. In particular, it gives no condition-specific least-squares means, estimated difference, standard error, confidence interval, or p-value. As a result, the posted results do not quantify whether RBANS scores differed between Niagen and placebo, the direction of any difference, or the precision of an estimate. They also do not establish that the conditions were equivalent or that there was no difference.
In general, an outcome’s measurement scale helps explain what a score represents, but a scale description is not a finding about participants in a trial. The RBANS description says that higher scores indicate normal cognition and gives reference information about the score range and mean. It does not provide the participants’ baseline scores or their scores under either condition. Similarly, enrollment and completer counts describe the study population and follow-up, but cannot substitute for an outcome estimate.
The adverse-event counts provide a separate description of events recorded in each sequence period. They should not be read as proof that an event was caused by either condition, and they do not answer the primary cognitive question. The record’s serious-event terms and percentages are not accompanied by the denominator and period details needed for a treatment-specific rate interpretation.
Thus, the registry record supports a description of the trial’s design and measurement strategy, but not a conclusion about the comparative cognitive outcome. The missing analysis result is central: without an estimate and its uncertainty, the magnitude, precision, and statistical compatibility of possible differences cannot be assessed from the posted results.
13. Why This Trial Matters Statistically
This trial illustrates why design details and outcome results answer different questions. The registry describes a randomized crossover comparison with two treatment orders, masking, and repeated RBANS assessments. Those details identify how the study intended to compare conditions. They do not show the size or uncertainty of the resulting comparison, because the numerical primary-outcome analysis is not reported in the registry record.
Crossover studies can be informative because participants receive both conditions, allowing within-participant comparisons in general. At the same time, repeated treatment periods make the handling of time, sequence, and possible carryover important. A reader needs the analysis model and numerical results to determine how the design translated into an estimate. The registry record does not report those statistical details.
The case also shows why a stated outcome measure should not be mistaken for an outcome finding. The RBANS has a described scale, and the record gives the planned assessment times and completer counts. These registry entries help define the measurement and analysis population, but without the estimated treatment contrast and its uncertainty, they do not quantify what happened to scores under the two conditions.
Finally, registry completeness matters for interpreting both efficacy-oriented outcomes and safety counts. The adverse-event entries offer period-specific counts, while the primary cognitive analysis is absent. Keeping these types of information separate prevents event counts or design features from being treated as evidence about the unreported primary outcome. The statistical lesson is not that the treatment comparison had a particular result, but that a study’s design, measure, and numerical analysis are distinct components of the evidence needed for interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting the primary question is that the registry record does not report numerical RBANS results. Without an estimated difference and its uncertainty, the direction, magnitude, and precision of the comparison cannot be evaluated. The record lists zero analyses despite identifying the primary outcome and the number of participants who completed the trial.
The outcome description names assessments at baseline, crossover, and the end of the study, but the record does not give score summaries for those time points or explain which contrast was estimated. It does not report the statistical model, treatment-effect estimate, confidence interval, or p-value. The handling of period and sequence effects, and any assessment of carryover, is not reported in the registry record. A washout period is also not reported.
The stated analysis population consists of participants who completed the trial: 20 in Sequence 1 and 17 in Sequence 2. The record does not explain how this population was defined, how participants who did not complete were handled, whether any outcome data were missing, or what methods were used for missing data. It does not identify the analysis as intention-to-treat or report sensitivity analyses.
Although the outcome description includes multiple assessment times, the record does not report a multiplicity strategy or enough detail to determine which time-point comparisons were tested. It also does not report a statistical analysis plan, interim analyses, or the trial’s own sample-size justification. The listed adverse-event terms and percentages lack reported denominator and period links. These omissions limit interpretation of the posted record; they do not establish what analyses were conducted outside the registry or what results they produced.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment — NCT04078178.
- Registry record last updated 2024-11-29; status last verified 2024-11.
- Results first posted 2024-11-29.
- 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
NCT04078178 is a completed randomized, quadruple-masked, placebo-controlled crossover trial of Niagen and placebo in people with subjective cognitive decline or mild cognitive impairment. Enrollment was 61. Participants were assigned to Niagen followed by placebo or placebo followed by Niagen, with each period lasting 8 weeks. The primary outcome was cognition measured with the RBANS at baseline, crossover, and the end of study.
The primary outcome description states that trial completers were analyzed: 20 in Sequence 1 and 17 in Sequence 2. The registry record does not report numerical results for the primary outcome or the statistical analysis details needed to assess the comparison. Adverse-event counts and deaths are listed by sequence period; zero deaths are reported in every listed group.