Trial Outcomes & Findings for Tooth Sensitivity Relief by Two Mouthrinses (NCT NCT01133379)

NCT ID: NCT01133379

Last Updated: 2015-07-09

Results Overview

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 174 participants
• Primary outcome timeframe: 6 Weeks
• Results posted on: 2015-07-09

Participant Flow

Participant milestones

Measure	12027-021 (Vehicle Control) Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Overall Study STARTED	58	58	58
Overall Study COMPLETED	57	56	56
Overall Study NOT COMPLETED	1	2	2

Reasons for withdrawal

Measure	12027-021 (Vehicle Control) Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Overall Study Withdrawal by Subject	0	1	1
Overall Study Lost to Follow-up	1	1	1

Baseline Characteristics

Tooth Sensitivity Relief by Two Mouthrinses

Baseline characteristics by cohort

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)	Total n=174 Participants Total of all reporting groups
Age, Continuous	35.2 years STANDARD_DEVIATION 11.36 • n=93 Participants	33.9 years STANDARD_DEVIATION 10.98 • n=4 Participants	35.8 years STANDARD_DEVIATION 11.98 • n=27 Participants	35.0 years STANDARD_DEVIATION 11.41 • n=483 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	42 Participants n=4 Participants	42 Participants n=27 Participants	127 Participants n=483 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	16 Participants n=4 Participants	16 Participants n=27 Participants	47 Participants n=483 Participants
Region of Enrollment USA	58 participants n=93 Participants	58 participants n=4 Participants	58 participants n=27 Participants	174 participants n=483 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity Score at Week 6	37.91 grams Standard Error 3.342	36.77 grams Standard Error 3.362	30.16 grams Standard Error 3.362

PRIMARY outcome

Timeframe: 4 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity Score at Week 4	30.58 grams Standard Error 2.793	31.69 grams Standard Error 2.809	25.66 grams Standard Error 2.809

PRIMARY outcome

Timeframe: 2 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity Score at Week 2	22.27 grams Standard Error 1.838	22.59 grams Standard Error 1.849	18.28 grams Standard Error 1.849

PRIMARY outcome

Timeframe: 1 Week

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity Score at Week 1	15.99 grams Standard Error 0.944	15.04 grams Standard Error 0.941	15.03 grams Standard Error 0.941

SECONDARY outcome

Timeframe: 1 Week

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity VAS Score at Week 1	40.09 units on a scale (mm) Standard Error 1.926	39.61 units on a scale (mm) Standard Error 1.927	39.27 units on a scale (mm) Standard Error 1.926

SECONDARY outcome

Timeframe: 2 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity VAS Score at Week 2	37.69 units on a scale (mm) Standard Error 2.010	35.71 units on a scale (mm) Standard Error 2.028	34.79 units on a scale (mm) Standard Error 2.027

SECONDARY outcome

Timeframe: 4 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity VAS Score at Week 4	31.06 units on a scale (mm) Standard Error 2.448	29.25 units on a scale (mm) Standard Error 2.469	32.97 units on a scale (mm) Standard Error 2.469

SECONDARY outcome

Timeframe: 6 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Tactile Sensitivity VAS Score at Week 6	25.50 units on a scale (mm) Standard Error 2.541	24.80 units on a scale (mm) Standard Error 2.563	26.86 units on a scale (mm) Standard Error 2.563

SECONDARY outcome

Timeframe: 1 Week

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Cold Air Stimulus VAS Score at Week 1	44.18 units on a scale (mm) Standard Error 1.894	41.72 units on a scale (mm) Standard Error 1.893	40.30 units on a scale (mm) Standard Error 1.893

SECONDARY outcome

Timeframe: 2 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Cold Air Stimulus VAS Score at Week 2	40.56 units on a scale (mm) Standard Error 2.277	37.95 units on a scale (mm) Standard Error 2.296	36.90 units on a scale (mm) Standard Error 2.296

SECONDARY outcome

Timeframe: 4 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Cold Air Stimulus VAS Score at Week 4	31.92 units on a scale (mm) Standard Error 2.534	31.87 units on a scale (mm) Standard Error 2.556	30.63 units on a scale (mm) Standard Error 2.555

SECONDARY outcome

Timeframe: 6 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Mean Cold Air Stimulus VAS Score at Week 6	26.61 units on a scale (mm) Standard Error 2.597	25.40 units on a scale (mm) Standard Error 2.619	26.28 units on a scale (mm) Standard Error 2.618

SECONDARY outcome

Timeframe: 1 Week

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=58 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Global Subjective VAS Score at Week 1	47.54 units on a scale (mm) Standard Error 1.675	48.51 units on a scale (mm) Standard Error 1.676	47.28 units on a scale (mm) Standard Error 1.677

SECONDARY outcome

Timeframe: 2 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.

Outcome measures

Measure	12027-021 (Vehicle Control) n=58 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=57 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Global Subjective VAS Score at Week 2	44.12 units on a scale (mm) Standard Error 2.108	37.93 units on a scale (mm) Standard Error 2.128	38.02 units on a scale (mm) Standard Error 2.129

SECONDARY outcome

Timeframe: 4 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Global Subjective VAS Score at Week 4	35.92 units on a scale (mm) Standard Error 2.480	33.60 units on a scale (mm) Standard Error 2.503	31.85 units on a scale (mm) Standard Error 2.504

SECONDARY outcome

Timeframe: 6 Weeks

Population: Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.

At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.

Outcome measures

Measure	12027-021 (Vehicle Control) n=57 Participants Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)	12027-019 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)	12027-020 n=56 Participants 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
Global Subjective VAS Score at Week 6	31.15 units on a scale (mm) Standard Error 2.593	26.74 units on a scale (mm) Standard Error 2.617	25.31 units on a scale (mm) Standard Error 2.619

Adverse Events

12027-021 (Vehicle Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12027-019

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12027-020

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Lynch, DMD, PhD/Study Director

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 908-433-6423 USA EST

Email: mlynch23@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER