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The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.
Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a general consensus that level of fluoride in plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to the diluting and washing effect of saliva followed by periodic swallowing. To evaluate fluoride content, plaque samples will be collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaF toothpaste (1450 parts per million [ppm] fluoride [F]) | Experimental | Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| NaF toothpaste (1400ppmF) | Active Comparator | Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF)) | Active Comparator | Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| Placebo toothpaste (0ppmF) | Placebo Comparator | Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Fluoride (NaF) | Drug | Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF |
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| Measure | Description | Time Frame |
|---|---|---|
| Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours | To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data. | Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours | To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
There was a four-day wash out prior to each treatment period during which participants used the study fluoride-free toothpaste. Two to three days prior to the start of each treatment visit, participants attended the study site for a dental prophylaxis then discontinued all oral hygiene prior to study treatment visit.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F) | Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| FG001 | NaF Toothpaste (1400ppmF) | Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| FG002 | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| FG003 | Placebo Toothpaste (0ppmF) | Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All randomized participants |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours | To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data. | Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Least Squares Mean | Standard Error | ln(μg*F*minutes/cm^2) | Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment |
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All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NaF Toothpaste(1450ppmF) | Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Placebo | Drug | Fluoride free toothpaste (0ppmF) |
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| Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment |
| Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | Plaque samples were collected at baseline, 15 minutes post single application of study treatment |
| Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | Plaque samples were collected at baseline, 30 minutes post single application of study treatment |
| Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | Plaque samples were collected at baseline, 1 hour post single application of study treatment |
| Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | Plaque samples were collected at baseline, 2 hour post single application of study treatment |
| Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | Plaque samples were collected at baseline, 4 hours post single application of study treatment |
| Other Reason |
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| COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 |
| NaF Toothpaste(1450 Ppm F) |
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| OG001 | NaF Toothpaste (1400 Ppm F) | Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
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| Secondary | Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours | To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data. | Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Log Mean | Standard Error | ln(μg*F*minutes/cm^2) | Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment |
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| Secondary | Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Median | Full Range | μg*F/g | Plaque samples were collected at baseline, 15 minutes post single application of study treatment |
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| Secondary | Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Median | Full Range | μg*F/g | Plaque samples were collected at baseline, 30 minutes post single application of study treatment |
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| Secondary | Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Median | Full Range | μg*F/g | Plaque samples were collected at baseline, 1 hour post single application of study treatment |
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| Secondary | Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Median | Full Range | μg*F/g | Plaque samples were collected at baseline, 2 hour post single application of study treatment |
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| Secondary | Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments | Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. | PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed. | Posted | Median | Full Range | μg*F/g | Plaque samples were collected at baseline, 4 hours post single application of study treatment |
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| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | NaF Toothpaste (1400ppmF) | Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. | 0 | 59 | 0 | 59 |
| EG002 | NaMFP/NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. | 0 | 61 | 0 | 61 |
| EG003 | Placebo Toothpaste (0ppmF) | Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. | 0 | 59 | 0 | 59 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D002327 |
| Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels. | ANCOVA | The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor. | <0.0001 | No adjustment was made for multiple comparisons because the comparisons were predefined. | Adjusted Mean Difference | 1.44 | 95 | 1.23 | 1.65 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels. | ANCOVA | The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor. | <0.0001 | No adjustment was made for multiple comparisons because the comparisons were predefined. | Adjusted Mean Difference | 0.49 | 95 | 0.28 | 0.70 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels. | ANCOVA | The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor. | <0.0001 | No adjustment was made for multiple comparisons because the comparison was predefined. | Adjusted Mean Difference | 1.44 | 2-Sided | 95 | 1.23 | 1.65 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels. | ANCOVA | The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor. | <0.0001 | No adjustment was made for multiple comparisons as the comparisons were predefined. | Adjusted Mean Difference | 0.95 | 2-Sided | 95 | 0.74 | 1.16 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 1.36 | 2-Sided | 95 | 0.69 | 2.36 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. Tests were 2-sided. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 3.01 | 2-Sided | 95 | 2.06 | 4.05 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.75 | 2-Sided | 95 | 0.41 | 1.27 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 2.10 | 2-Sided | 95 | 1.50 | 2.74 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 1.01 | 2-Sided | 95 | 0.73 | 1.35 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0003 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.40 | 2-Sided | 95 | 0.15 | 0.71 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.91 | 2-Sided | 95 | 0.58 | 1.56 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signal Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.36 | 2-Sided | 95 | 0.15 | 0.68 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.91 | 2-Sided | 95 | 0.58 | 1.35 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.37 | 2-Sided | 95 | 0.26 | 0.56 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.1756 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.04 | 2-Sided | 95 | -0.02 | 0.12 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.24 | 2-Sided | 95 | 0.16 | 0.38 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0023 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.11 | 2-Sided | 95 | 0.04 | 0.22 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.34 | 2-Sided | 95 | 0.22 | 0.51 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.18 | 2-Sided | 95 | 0.12 | 0.25 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0531 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.03 | 2-Sided | 95 | 0.00 | 0.07 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.10 | 2-Sided | 95 | 0.07 | 0.14 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0005 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.08 | 2-Sided | 95 | 0.03 | 0.15 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.12 | 2-Sided | 95 | 0.08 | 0.20 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.07 | 2-Sided | 95 | 0.04 | 0.10 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0726 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.02 | 2-Sided | 95 | 0.00 | 0.04 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.04 | 2-Sided | 95 | 0.03 | 0.06 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0107 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.03 | 2-Sided | 95 | 0.01 | 0.06 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | <0.0001 | Median Difference (Final Values) | 0.05 | 2-Sided | 95 | 0.03 | 0.07 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level. | Wilcoxon Signed Rank Test | 0.0012 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Median Difference (Final Values) | 0.03 | 2-Sided | 95 | 0.01 | 0.04 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |