Trial Outcomes & Findings for A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks (NCT NCT04050722)

Last Updated: 2020-11-19

Results Overview

BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

130 participants

Primary outcome timeframe

Week 3

Results posted on

2020-11-19

Participant Flow

Participants were recruited from one center in United States.

A total of 154 participants were screened, of whom 130 were randomized for treatment, 17 were screen failures, 3 withdrew consent prior to randomization, and 4 were not randomized as sufficient participants were already enrolled in the study.

Participant milestones

Participant milestones
Measure	Sensodyne Repair and Protect (Test Dentifrice) Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 percent (%) stannous fluoride (SnF2) (1100 parts per million \[ppm\] fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as sodium monofluorophosphate (SMFP) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Overall Study STARTED	65	65
Overall Study COMPLETED	64	65
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sensodyne Repair and Protect (Test Dentifrice) Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 percent (%) stannous fluoride (SnF2) (1100 parts per million \[ppm\] fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as sodium monofluorophosphate (SMFP) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Total n=130 Participants Total of all reporting groups
Age, Continuous	39.3 Years STANDARD_DEVIATION 11.50 • n=5 Participants	39.6 Years STANDARD_DEVIATION 12.48 • n=7 Participants	39.4 Years STANDARD_DEVIATION 11.95 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	32 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 3

Population: Modified intent-to-treat (m-ITT) population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number of participants analyzed indicates participants with available data for this outcome measure at specified time point.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Whole Mouth Mean Bleeding Index (BI) at Week 3	0.14 score on a scale Standard Deviation 0.071	0.20 score on a scale Standard Deviation 0.066

SECONDARY outcome

Timeframe: Week 2

Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy.

BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Whole Mouth Mean Bleeding Index (BI) at Week 2	0.15 score on a scale Standard Deviation 0.072	0.22 score on a scale Standard Deviation 0.073

SECONDARY outcome

Timeframe: Week 2 and Week 3

Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point.

Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 At Week 2	21.0 number of bleeding sites Standard Deviation 10.14	31.7 number of bleeding sites Standard Deviation 10.93
Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 At Week 3	19.7 number of bleeding sites Standard Deviation 10.17	28.0 number of bleeding sites Standard Deviation 9.60

SECONDARY outcome

Timeframe: Week 2 and Week 3

MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as \[1\] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Mean Modified Gingival Index (MGI) at Week 2 and Week 3 At Week 2	2.08 score on a scale Standard Deviation 0.142	2.18 score on a scale Standard Deviation 0.113
Mean Modified Gingival Index (MGI) at Week 2 and Week 3 At Week 3	2.05 score on a scale Standard Deviation 0.152	2.15 score on a scale Standard Deviation 0.124

SECONDARY outcome

Timeframe: Week 2 and Week 3

TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(\<)1/3 of tooth surface,4-plaque covering more than or equal to (\>=)1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 At Week 2	2.35 score on a scale Standard Deviation 0.333	2.81 score on a scale Standard Deviation 0.307
Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 At Week 3	2.33 score on a scale Standard Deviation 0.420	2.76 score on a scale Standard Deviation 0.303

SECONDARY outcome

Timeframe: Week 2 and Week 3

TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering \<1/3 of tooth surface,4-plaque covering \>=1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported.

Outcome measures

Outcome measures
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=64 Participants Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 Participants Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 At Week 2	2.48 score on a scale Standard Deviation 0.338	2.90 score on a scale Standard Deviation 0.279
Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 At Week 3	2.47 score on a scale Standard Deviation 0.421	2.88 score on a scale Standard Deviation 0.273

Adverse Events

Sensodyne Repair and Protect (Test Dentifrice)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Colgate Cavity Protection (Negative Control Dentifrice)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sensodyne Repair and Protect (Test Dentifrice) n=65 participants at risk Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.	Colgate Cavity Protection (Negative Control Dentifrice) n=65 participants at risk Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
Injury, poisoning and procedural complications Gingival injury	1.5% 1/65 • Number of events 1 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.	1.5% 1/65 • Number of events 1 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
Injury, poisoning and procedural complications Traumatic ulcer	3.1% 2/65 • Number of events 2 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.	0.00% 0/65 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
Gastrointestinal disorders Dry mouth	1.5% 1/65 • Number of events 1 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.	1.5% 1/65 • Number of events 1 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
Gastrointestinal disorders Gingival ulceration	0.00% 0/65 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.	1.5% 1/65 • Number of events 3 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
Infections and infestations Angular cheilitis	1.5% 1/65 • Number of events 2 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.	0.00% 0/65 • Up to 28 days Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER