## Protocol Section
### Identification Module
**NCT ID:** NCT02234479

**Brief Title:** MediHoney for Radiation Dermatitis

**Official Title:** A Pilot Study: Topical Application of Medihoney for Management of Radiation Dermatitis

#### Organization Study ID Info
**ID:** HP-00058645
#### Organization
**Class:** OTHER
**Full Name:** University of Maryland, Baltimore
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-08-08

**Type:** ESTIMATED

**Results First Submit Date:** 2016-02-23

**Results First Submit QC Date:** 2016-06-27

#### Start Date
**Date:** 2014-06

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2014-09-09
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-02
**Study First Submit QC Date:** 2014-09-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Integra LifeSciences Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Maryland, Baltimore

#### Responsible Party

**Investigator Affiliation:** University of Maryland, Baltimore

**Investigator Full Name:** Department of Radiation Oncology

**Investigator Title:** Principle Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.

**Detailed Description:** Background: Radiation dermatitis, also known as radiodermatitis or radiation skin reaction, is a widely reported side effect of radiation therapy in cancer. The most common radiation therapy-induced side effect is acute skin reaction, which can range from mild erythema to confluent moist desquamation. Almost all patients receiving radiation therapy have a risk of developing radiation dermatitis (Trueman, 2012).

When not managed appropriately, radiation dermatitis can affect patients' physical functioning and quality of life. It can also cause pain and discomfort and may result in infection and/or interruption of treatment (Feight et al., 2011). An important role for oncology nurses is in educating, assessing, and monitoring patients for radiation dermatitis. Many nursing interventions are in use, including those based on tradition, physician preference, and published reports. In routine practice, most interventions for radiation dermatitis are institution-specific and not reliably evidence based.

At the investigators institution, Hydrophor (Aquaphor), an ointment containing petrolatum, mineral oil, ceresin, and lanolin alcohol is the current standard of care for preventing and treating radiation dermatitis. Some women under treatment for breast cancer report disliking the smell and/or texture of Hydrophor. Rarely reported side effects have included allergic reactions, burning, stinging, and/or redness. Honey is an ancient remedy that has most recently shown promising results in treating burns, oral infections, and promoting surgical wound healing and palliation. The topical application of honey has been reported to be advantageous in radiation mucositis (Biswal et al., 2003). In a continuing effort to identify those treatment options that can make the investigators patients more comfortable and reduce complications from radiation dermatitis, the investigators are interested in conducting a small pilot study comparing the effectiveness of a honey-based treatment (Medihoney) with that of the investigators current standard of care (Hydrophor).

### Conditions Module

**Conditions:**

- Breast Cancer

- Radiation Dermatitis

**Keywords:**

- Breast Cancer

- Radiation Dermatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

**Intervention Names:**

- Biological: Hydrophor (Group A)

**Label:** Hydrophor (Group A)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

**Intervention Names:**

- Biological: MediHoney (Group B)

**Label:** MediHoney (Group B)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hydrophor (Group A)

**Description:** * Rehydrates dry, chapped or chafed skin
* May be used alone as a skin lubricant or protectant

**Name:** Hydrophor (Group A)

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- MediHoney (Group B)

**Description:** It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:

* Maintain a balanced environment for healing.
* Aids in reducing dermatitis.
* Reduce affected area pH.2-3

**Name:** MediHoney (Group B)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.

**Measure:** Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Breast cancer treated with either lumpectomy or mastectomy (with or without reconstruction).
* The patient must be female.
* Radiation therapy planned to whole breast/chestwall area (can include lymph node radiation; conventional 3D radiation, IMRT/IGRT, and hypofractionation are all allowed).
* Age ≥ 18 years old.

Exclusion Criteria:

* Previous radiation therapy to chest area that would result in overlapping radiation fields.
* Wound care issues.
* Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy (concurrent Herceptin and/or tamoxifen/aromatase inhibitors and RT is allowed).
* Patients receiving HDR (savi or mammosite) brachytherapy treatments.
* Patients with an allergy and/or sensitivity to Hydrophor, honey, and/or Medihoney.
* Immunocompromised status.
* Age \< 18 years old.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland

**State:** Maryland

**Zip:** 21201

#### Overall Officials

**Official 1:**

**Affiliation:** University of Maryland, College Park

**Name:** Elizabeth Nichols, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000011832

- Term: Radiation Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M14701

- Name: Radiodermatitis

- Relevance: HIGH

- As Found: Radiation Dermatitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14679

- Name: Radiation Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003872

- Term: Dermatitis

- ID: D000011855

- Term: Radiodermatitis

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Hydrophor (Group A)

**Description:** Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin

•May be used alone as a skin lubricant or protectant

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 16

**Serious Number At Risk:** 16

**Title:** Hydrophor (Group A)

**Group ID:** EG001

**Title:** MediHoney (Group B)

**Description:** Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:

* Maintain a balanced environment for healing.
* Aids in reducing dermatitis.
* Reduce affected area pH.2-3

**ID:** EG001

**Other Num at Risk:** 18

**Serious Number At Risk:** 18

**Title:** MediHoney (Group B)

**Frequency Threshold:** 0

#### Other Events

**Term:** dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 10.0

**Time Frame:** Adverse event data were collected in a 6 month period.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 18

**Group ID:** BG002

**Value:** 34

**Units:** Participants

### Group

**ID:** BG000

**Title:** Hydrophor (Group A)

**Description:** Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin

•May be used alone as a skin lubricant or protectant

### Group

**ID:** BG001

**Title:** MediHoney (Group B)

**Description:** Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:

* Maintain a balanced environment for healing.
* Aids in reducing dermatitis.
* Reduce affected area pH.2-3

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 34

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 18

**Upper Limit:** 75

**Value:** 40

#### Measurement

**Group ID:** BG001

**Lower Limit:** 18

**Upper Limit:** 75

**Value:** 40

#### Measurement

**Group ID:** BG002

**Lower Limit:** 18

**Upper Limit:** 75

**Value:** 40

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 34

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 24

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 34

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** enichols1@umm.edu
**Organization:** University of Maryland
**Phone:** 410-328-2324
**Title:** Elizabeth Nichols, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.
**Parameter Type:** NUMBER
**Population Description:** Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin

•May be used alone as a skin lubricant or protectant
**ID:** OG000
**Title:** Hydrophor (Group A)
##### Group
**Description:** Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:

* Maintain a balanced environment for healing.
* Aids in reducing dermatitis.
* Reduce affected area pH.2-3
**ID:** OG001
**Title:** MediHoney (Group B)
### Participant Flow Module
#### Group
**Description:** Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin

•May be used alone as a skin lubricant or protectant
**ID:** FG000
**Title:** Hydrophor (Group A)
#### Group
**Description:** Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:

* Maintain a balanced environment for healing.
* Aids in reducing dermatitis.
* Reduce affected area pH.2-3
**ID:** FG001
**Title:** MediHoney (Group B)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 18
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 15
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Has Results:** True