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The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds. |
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| Test Product 2 | Other | Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotene mouthwash | Other | Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome.. | Within 2 minutes post product use |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use. |
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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 |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
A total 58 participants were screened, out of which 56 participants were enrolled in the study. Two participants were not enrolled as they did not meet the study criteria. Of 56 enrolled participants, 55 participants were randomized as one participant withdrew consent.
Participants were recruited at a single center in United states of America (U.S.A)
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Oral Rinse/Mineral Water | Participants were supervised to rinse their mouth with 15 milliliter (mL) of the experimental oral rinse/mouth wash swishing followed by with 15mL of mineral water swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days. |
| FG001 | Mineral Water/Experimental Oral Rinse | Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing followed by with 15mL of experimental oral rinse/mouth wash swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment. |
| Units | Counts |
|---|---|
| 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 | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome.. | Analysis for this outcome was performed on intent to treat (ITT) population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. | Posted | Count of Participants | Participants | Within 2 minutes post product use |
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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 | Experimental Oral Rinse | Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental mouth wash use was permitted. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyst | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Bottled mineral water | Other | Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. |
|
| Within 2 minutes post product use |
| Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No) | Within 30 ± 5 minutes post product use |
| Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect. | Within 5 minutes post product use |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Mineral Water | Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water. |
|
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| Secondary | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use. | ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. Note: Number of participants who answered question 6 proceeded to answer question 7. Participants also chosen more than one answer for question 7. | Posted | Count of Participants | Participants | Within 2 minutes post product use |
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|
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| Secondary | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No) | Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. | Posted | Count of Participants | Participants | Within 30 ± 5 minutes post product use |
|
|
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| Secondary | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect. | Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. | Posted | Count of Participants | Participants | Within 5 minutes post product use |
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| 0 |
| 55 |
| 0 |
| 55 |
| 1 |
| 55 |
| EG001 | Mineral Water | Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water. | 0 | 55 | 0 | 55 | 0 | 55 |
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.
| Q3: Liked it very much |
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| Q3: Liked it somewhat |
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| Q3: Liked it slightly |
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| Q3: Did not like it that much |
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| Q3: Did not Like it at all |
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| Q4: Liked it extremely |
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| Q4: Liked it very much |
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| Q4: Liked it somewhat |
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| Q4: Liked it slightly |
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| Q4: Did not like it that much |
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| Q4: Did not Like it at all |
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| Q5: Strongest flavor imaginable |
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| Q5: Very strong |
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| Q5: Strong |
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| Q5: Moderate |
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| Q5: Weak |
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| Q5: Barely detectable |
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| Q5: No flavor at all |
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| Q6(Moisturizing): None |
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| Q6(Moisturizing): Mild |
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| Q6(Moisturizing): Moderate |
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| Q6(Moisturizing): Severe |
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| Q7(Moisturizing)Initially-first contact with mouth |
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| Q7Moisturizing:During use-whilst swishing in mouth |
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| Q7Moisturizing:After use-spitting out product |
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| Q6(Soothing): None |
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| Q6(Soothing): Mild |
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| Q6(Soothing): Moderate |
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| Q6(Soothing): Severe |
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| Q7(Soothing): Initially - first contact with mouth |
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| Q7(Soothing): During use -whilst swishing in mouth |
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| Q7(Soothing):After use-after spitting out product |
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| Q6(Refreshing): None |
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| Q6(Refreshing): Mild |
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| Q6(Refreshing): Moderate |
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| Q6(Refreshing): Severe |
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| Q6(Refreshing): Missing |
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| Q7(Refreshing): Initially-first contact with mouth |
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| Q7(Refreshing):During use-whilst swishing in mouth |
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| Q7(Refreshing)After use-after spitting out product |
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| Q6(Tingling): None |
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| Q6(Tingling): Mild |
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| Q6(Tingling): Moderate |
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| Q6(Tingling): Severe |
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| Q6(Tingling): Missing |
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| Q7(Tingling): Initially-first contact with mouth |
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| Q7(Tingling):During use - whilst swishing in mouth |
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| Q7(Tingling):After use -after spitting out product |
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| Q6(Numbing): None |
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| Q6(Numbing): Mild |
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| Q6(Numbing): Moderate |
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| Q6(Numbing): Severe |
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| Q6(Numbing): Missing |
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| Q7(Numbing): Initially-first contact with mouth |
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| Q7(Numbing):During use - whilst swishing in mouth |
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| Q7(Numbing):After use - after spitting out product |
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| Q6(Burning): None |
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| Q6(Burning): Mild |
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| Q6(Burning): Moderate |
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| Q6(Burning): Severe |
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| Q6(Burning): Missing |
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| Q7(Burning): Initially-first contact with mouth |
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| Q7(Burning):During use - whilst swishing in mouth |
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| Q7(Burning):After use - after spitting out product |
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| Q6(Drying Out): None |
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| Q6(Drying Out): Mild |
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| Q6(Drying Out): Moderate |
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| Q6(Drying Out): Severe |
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| Q6(Drying Out): Missing |
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| Q7(Drying Out): Initially-first contact with mouth |
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| Q7(Drying Out):During use-whilst swishing in mouth |
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| Q7(Drying Out)After use-after spitting out product |
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| Q1: Moisturizing: Moderate |
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| Q1: Moisturizing: Severe |
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| Q1: Soothing: None |
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| Q1: Soothing: Mild |
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| Q1: Soothing: Moderate |
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| Q1: Soothing: Severe |
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| Q1: Soothing: Missing |
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| Q1: Refreshing: None |
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| Q1: Refreshing: Mild |
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| Q1: Refreshing: Moderate |
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| Q1: Refreshing: Severe |
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| Q1: Refreshing: Missing |
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| Q1: Tingling: None |
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| Q1: Tingling: Mild |
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| Q1: Tingling: Moderate |
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| Q1: Tingling: Severe |
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| Q1: Tingling: Missing |
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| Q1: Numbing: None |
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| Q1: Numbing: Mild |
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| Q1: Numbing: Moderate |
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| Q1: Numbing: Severe |
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| Q1: Numbing: Missing |
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| Q1: Burning: None |
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| Q1: Burning: Mild |
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| Q1: Burning: Moderate |
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| Q1: Burning: Severe |
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| Q1: Burning: Missing |
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| Q1: Drying Out: None |
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| Q1: Drying Out: Mild |
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| Q1: Drying Out: Moderate |
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| Q1: Drying Out: Severe |
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| Q1: Drying Out: Missing |
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| Q2: Would You Continue Use of The Product? Yes |
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| Q2: Would You Continue Use of The Product? No |
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| Good |
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| Fair |
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| Poor |
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| Q2 |
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| Q3 |
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