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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months. |
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| Placebo Arm | Placebo Comparator | Participants in this arm will take a placebo product daily for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuBest Tall Growth Protein Powder | Dietary Supplement | NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change Mean Percentile Score in Double Trouble | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline and Month 6 |
| IChange Mean Percentile Score in Feature Match | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline and Month 6 |
| Change Mean Percentile Score in Grammatical Reasoning | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Digit Span | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Token Search | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Height | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | Baseline, Month 2, Month 4, and Month 6 |
| Changes in Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30). |
| FG001 | Placebo Arm | Participants in this arm will take a placebo product daily for 6 months (n=30). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30). |
| BG001 | Placebo Arm | Participants in this arm will take a placebo product daily for 6 months (n=30). |
| 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 | Change Mean Percentile Score in Double Trouble | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 6 |
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6 months.
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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 | Intervention Arm | Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner | Citruslabs | +1 805-876-4484 | hello@citruslabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2024 | May 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2024 | May 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A randomized, double-blind, placebo-controlled, two-arm trial.
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The study is double-blind; participants, care providers, investigators, and outcomes assessors are all masked to the allocation of intervention or placebo.
| Placebo Powder | Dietary Supplement | The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients. |
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| Baseline to Month 6 |
Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups.
| Baseline, Month 2, Month 4, and Month 6 |
| Changes in Overall Health as Reported by Parents | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of the Child's Health in the Future. | This parameter was assessed using a parent-completed questionnaire, with the question "I expect my child will have a very healthy life". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago. | This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Much worse," 5 = "Much Better"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Child's Energy Levels as Reported by Parents | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Completing High-Intensity Activity | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Completing Moderate-Intensity Activity | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Moving Around | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Limitations When Bending, Lifting, or Stooping. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Limitations During the Completion of Schoolwork or Activities. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Health Compared to Other Children. | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Immunity | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parents' Worry About Child's Health | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Stomach Aches | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | Monthly from Baseline to Month 6 |
| Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis) | This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test. | Baseline to Month 6 |
| Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Baseline to Month 6 |
| Increase in Height - Nubest Group Only (Within-Group Analysis) | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | Baseline to Month 6 |
| Increase in Height - Placebo Group Only (Within-Group Analysis) | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | Baseline to Month 6 |
| Changes in Weight - Nubest Group Only (Within-Group Analysis) | Weight measurement will be taken using a FitBit Smart Scale. | Baseline to Month 6 |
| Changes in Weight - Placebo Group Only (Within-Group Analysis) | Weight measurement will be taken using a FitBit Smart Scale. | Baseline to Month 6 |
| Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6. |
| Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6. |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6. |
| Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6. |
| Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Monthly from Baseline to Month 6 |
| Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Monthly from Baseline to Month 6 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | IChange Mean Percentile Score in Feature Match | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 6 |
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| Primary | Change Mean Percentile Score in Grammatical Reasoning | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline to Month 6 |
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| Primary | Change Mean Percentile Score in Digit Span | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline to Month 6 |
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| Primary | Change Mean Percentile Score in Token Search | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline to Month 6 |
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| Secondary | Increase in Height | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline, Month 2, Month 4, and Month 6 |
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| Secondary | Changes in Weight | Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline, Month 2, Month 4, and Month 6 |
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| Secondary | Changes in Overall Health as Reported by Parents | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parents' Perception of the Child's Health in the Future. | This parameter was assessed using a parent-completed questionnaire, with the question "I expect my child will have a very healthy life". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Much worse," 5 = "Much Better"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Child's Energy Levels as Reported by Parents | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Changes in Limitations When Completing High-Intensity Activity | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Changes in Limitations When Completing Moderate-Intensity Activity | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Changes in Limitations When Moving Around | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Limitations When Bending, Lifting, or Stooping. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Limitations During the Completion of Schoolwork or Activities. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parents' Perception of Child's Health Compared to Other Children. | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parents' Perception of Child's Immunity | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parents' Worry About Child's Health | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parent-reported Frequency of Child's Stomach Aches | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. | The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point. | Posted | Mean | Standard Deviation | percent change from baseline | Monthly from Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis) | This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis) | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | percentile score | Baseline to Month 6 |
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| Secondary | Increase in Height - Nubest Group Only (Within-Group Analysis) | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | inches | Baseline to Month 6 |
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| Secondary | Increase in Height - Placebo Group Only (Within-Group Analysis) | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | inches | Baseline to Month 6 |
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| Secondary | Changes in Weight - Nubest Group Only (Within-Group Analysis) | Weight measurement will be taken using a FitBit Smart Scale. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | Pounds | Baseline to Month 6 |
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| Secondary | Changes in Weight - Placebo Group Only (Within-Group Analysis) | Weight measurement will be taken using a FitBit Smart Scale. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | Pounds | Baseline to Month 6 |
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| Secondary | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6. |
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| Secondary | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6. |
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| Secondary | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6. |
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| Secondary | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6. |
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| Secondary | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
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|
| Secondary | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. | Within-group analysis. No between-group comparison reported for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Monthly from Baseline to Month 6 |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo Arm | Participants in this arm will take a placebo product daily for 6 months (n=30). | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
| Month 4 |
|
|
| Month 6 |
|
|
Comparison at Month 4 |
| Superiority |
| t-test, 2 sided | 0.954882 | Comparison at Month 6 | Superiority |
| Month 4 |
|
|
| Month 6 |
|
|
Comparison at Month 4 |
| Superiority |
| t-test, 2 sided | 0.726742 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.559556 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.952545 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.998367 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.999801 | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.993223 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999567 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.991697 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.581904 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999866 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.995044 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.998665 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999567 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.576782 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.772865 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.91384 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.992841 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.999801 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | >0.999999 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | >0.999999 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.998326 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.998665 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.998846 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | >0.999999 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.998367 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.999801 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.960874 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999567 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.767795 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.996139 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.952378 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.998846 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.576782 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.998665 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.989226 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999567 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.559556 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.997753 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.952378 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.988108 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.974102 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.998665 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999567 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.958944 | Comparison at Month 3 | Superiority |
| t-test, 2 sided | 0.998816 | Comparison at Month 4 | Superiority |
| t-test, 2 sided | 0.989226 | Comparison at Month 5 | Superiority |
| t-test, 2 sided | 0.999296 | Comparison at Month 6 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2 |
| Superiority |
| t-test, 2 sided | 0.999 | Comparison at Month 3. | Superiority |
| t-test, 2 sided | 0.999984 | Comparison at Month 4. | Superiority |
| t-test, 2 sided | 0.986557 | Comparison at Month 5. | Superiority |
| t-test, 2 sided | 0.998367 | Comparison at Month 6. | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2. |
| Superiority |
| t-test, 2 sided | 0.999801 | Comparison at Month 3. | Superiority |
| t-test, 2 sided | 0.998467 | Comparison at Month 4. | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5. | Superiority |
| t-test, 2 sided | 0.998846 | Comparison at Month 6. | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
Comparison at Month 2. |
| Superiority |
| t-test, 2 sided | 0.999801 | Comparison at Month 3. | Superiority |
| t-test, 2 sided | 0.963236 | Comparison at Month 4. | Superiority |
| t-test, 2 sided | 0.999816 | Comparison at Month 5. | Superiority |
| t-test, 2 sided | 0.737995 | Comparison at Month 6. | Superiority |
| Title | Measurements |
|---|
|
| Month 6 |
|
| 0.0033 |
Month 4 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0219 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|
|
| Month 6 |
|
| 0.239 |
Month 4 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.006 | Month 6 versus Baseline. | Superiority |
| Title |
|---|
| Measurements |
|---|
|
| Month 6 |
|
| 0.0001 |
Month 4 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | <0.0001 | Month 6 versus Baseline. | Superiority |
| Title |
|---|
| Measurements |
|---|
|
| Month 6 |
|
| 0.0124 |
Month 4 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0016 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.23 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0806 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0969 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.6098 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0369 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.6328 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0026 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0012 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0118 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0221 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.3682 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.6098 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.5691 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.6983 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.5749 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.4873 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.9998 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.819 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.8495 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.1951 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis. | 0.0806 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.6983 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.1062 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0333 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0734 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0219 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.982 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.091 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.4449 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0204 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0256 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.0403 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.0638 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.7195 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.1856 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.1222 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.982 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 3 vs Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 vs Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 vs Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.9951 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.999 | Month 3 versus Baseline | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.9913 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.4517 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.8187 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.9591 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.9994 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.9936 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.8526 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.4375 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.7477 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.297 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.3503 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.297 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.4449 | Month 6 versus Baseline. | Superiority |
| Title | Measurements |
|---|---|
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| >0.9999 |
Month 2 versus Baseline. |
| Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.9188 | Month 3 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 4 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | 0.3503 | Month 5 versus Baseline. | Superiority |
| t-test, 2 sided | Within-group analysis only. | >0.9999 | Month 6 versus Baseline. | Superiority |