## Protocol Section
### Identification Module
**NCT ID:** NCT03630679

**Brief Title:** A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot

**Official Title:** A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants

#### Organization Study ID Info
**ID:** OBVIO-DAN-003
#### Organization
**Class:** INDUSTRY
**Full Name:** Danone Asia Pacific Holdings Pte, Ltd.
### Status Module
#### Completion Date
**Date:** 2019-05-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-13

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-03-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-08-03

**Type:** ACTUAL

**Results First Submit Date:** 2020-06-24

**Results First Submit QC Date:** 2020-07-16

#### Start Date
**Date:** 2018-11-07

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2018-08-15
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-17
**Study First Submit QC Date:** 2018-08-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** KK Women's and Children's Hospital

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Danone Asia Pacific Holdings Pte, Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

**Detailed Description:** 20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared.

An evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted

### Conditions Module

**Conditions:**

- Preterm Birth

- Healthy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 45

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** born at \<37 weeks of gestation

**Label:** Preterm

#### Arm Group 2

**Description:** born at \>/= 37 weeks of gestation

**Label:** Full term Term

### Outcomes Module

#### Other Outcomes

**Description:** Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire

**Measure:** Satisfaction Scale Scores for Chatbot and ClaimIt

**Time Frame:** 8 weeks

#### Primary Outcomes

**Description:** Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot

**Measure:** Number of Chats on Sleep, Stress and Infant Nutrition

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants

**Measure:** Ratings by Parents of Quality of Their Sleep

**Time Frame:** 8 weeks

**Description:** Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants

**Measure:** Particular Reasons for Stress Caused by the Baby

**Time Frame:** 8 weeks

**Description:** Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula

**Measure:** Number of Chats on Feedings Among Parents Who Give Their Infants Formula

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Subjects (parent and infant) must meet the following criteria:

* Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment
* Infants must be at home (discharged from the hospital) at time of enrollment
* Informed consent from parent whose age is ≥21 years
* Parent must be proficient in the English language
* Parent must be able to comply with the required study tasks, as per PI's judgment
* In-home access to reliable internet connections; a mobile device suitable for electronic communication

Exclusion Criteria:

Infant must not meet any of the following criteria:

* Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)
* Must not be currently participating in any other clinical study

Parent must not meet any of the following criteria:

* Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:
* Presence of current mental illness or history of mental illness
* Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment
* Must not be a single parent
* Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements

**Healthy Volunteers:** True

**Maximum Age:** 6 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** * 20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment
* 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Singapore

**Country:** Singapore

**Facility:** KK Women's and Children's Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** KK Women's and Children's Hospital

**Name:** Mei Chien Chua, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Wong J, Foussat AC, Ting S, Acerbi E, van Elburg RM, Mei Chien C. A Chatbot to Engage Parents of Preterm and Term Infants on Parental Stress, Parental Sleep, and Infant Feeding: Usability and Feasibility Study. JMIR Pediatr Parent. 2021 Oct 26;4(4):e30169. doi: 10.2196/30169.

**PMID:** 34544679

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-08-31

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 647266

- Type Abbrev: Prot

- Upload Date: 2020-03-13T03:21

- Date: 2019-04-11

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 3020813

- Type Abbrev: SAP

- Upload Date: 2020-03-19T02:23

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm Birth

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Preterm

**Deaths Num At Risk:** 20

**Description:** born at \<37 weeks of gestation

**ID:** EG000

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Preterm

**Group ID:** EG001

**Title:** Full Term Term

**Deaths Num At Risk:** 25

**Description:** born at \>/= 37 weeks of gestation

**ID:** EG001

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Full Term Term

**Frequency Threshold:** 0

**Time Frame:** duration of the study - 4 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 45

**Units:** Participants

### Group

**ID:** BG000

**Title:** Preterm

**Description:** born at \<37 weeks of gestation

### Group

**ID:** BG001

**Title:** Full Term Term

**Description:** born at \>/= 37 weeks of gestation

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** 21-25 years old

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** 26-30 years old

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** 31-35 years old

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** 36-40 years old

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** 41-45 years old

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 45

**Class Title:** Parent's age

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 45

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 45

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 45

**Class Title:** Singapore

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** jill.wong@danone.com
**Organization:** Danone Asia Pacific Holdings
**Phone:** 82281172
**Title:** Digital Project Manager
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 131
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 125
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.96
- **Upper Limit:** 
- **Value:** 3.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.82
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.85
- **Upper Limit:** 
- **Value:** 3.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.76
- **Upper Limit:** 
- **Value:** 3.92
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Number of Chats on Sleep, Stress and Infant Nutrition
**Type:** PRIMARY
**Unit of Measure:** Chats
##### Group
**Description:** born at \<37 weeks of gestation
**ID:** OG000
**Title:** Preterm
##### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** OG001
**Title:** Full Term Term
#### Outcome Measure 2
**Description:** Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants
**Parameter Type:** NUMBER
**Population Description:** Per Protocol
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Ratings by Parents of Quality of Their Sleep
**Type:** SECONDARY
**Unit of Measure:** chat responses
##### Group
**Description:** born at \<37 weeks of gestation
**ID:** OG000
**Title:** Preterm
##### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** OG001
**Title:** Full Term Term
#### Outcome Measure 3
**Description:** Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants
**Parameter Type:** NUMBER
**Population Description:** Per Protocol
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Particular Reasons for Stress Caused by the Baby
**Type:** SECONDARY
**Unit of Measure:** chat responses
##### Group
**Description:** born at \<37 weeks of gestation
**ID:** OG000
**Title:** Preterm
##### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** OG001
**Title:** Full Term Term
#### Outcome Measure 4
**Description:** Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula
**Parameter Type:** NUMBER
**Population Description:** Per Protocol
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Number of Chats on Feedings Among Parents Who Give Their Infants Formula
**Type:** SECONDARY
**Unit of Measure:** chat responses
##### Group
**Description:** born at \<37 weeks of gestation
**ID:** OG000
**Title:** Preterm
##### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** OG001
**Title:** Full Term Term
#### Outcome Measure 5
**Description:** Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Satisfaction Scale Scores for Chatbot and ClaimIt
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** score on a scale
##### Group
**Description:** born at \<37 weeks of gestation
**ID:** OG000
**Title:** Preterm
##### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** OG001
**Title:** Full Term Term
### Participant Flow Module
#### Group
**Description:** born at \<37 weeks of gestation
**ID:** FG000
**Title:** Preterm
#### Group
**Description:** born at \>/= 37 weeks of gestation
**ID:** FG001
**Title:** Full Term Term
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
**Has Results:** True