## Protocol Section
### Identification Module
**NCT ID:** NCT02914379

**Brief Title:** A Study of LY3337641 in Healthy Male Participants

**Official Title:** Disposition of [¹⁴C]-LY3337641 Following Oral Administration in Healthy Male Subjects

#### Organization Study ID Info
**ID:** 16297
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** I8K-MC-JPDE
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-25

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-08-25

**Type:** ACTUAL

**Results First Submit Date:** 2022-10-11

**Results First Submit QC Date:** 2022-10-11

#### Start Date
**Date:** 2016-09

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2016-09-26
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-21
**Study First Submit QC Date:** 2016-09-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.

Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).

This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity.

**Intervention Names:**

- Drug: [¹⁴C]-LY3337641

**Label:** 20mg [¹⁴C]-LY3337641

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 20mg [¹⁴C]-LY3337641

**Description:** Administered orally

**Name:** [¹⁴C]-LY3337641

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.

**Measure:** Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

**Time Frame:** Baseline up to 22 days

**Description:** Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.

**Measure:** Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

**Time Frame:** Baseline up to 22 days

#### Secondary Outcomes

**Measure:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

**Measure:** Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces

**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Overtly healthy males, as determined by medical history and physical examination
* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)
* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have venous access sufficient to allow for blood sampling as per the protocol
* Are able and willing to give signed informed consent
* Generally have a minimum of 1 bowel movement per day

Exclusion Criteria:

* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological, dermatologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing
* Have donated blood of more than 500 milliliter (mL) within the month prior to screening
* Have an average weekly alcohol intake that exceeds 21 units per week, and are unwilling to stop alcohol consumption for 48 hours prior to admission, and while resident in the clinical research unit (CRU)
* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
* Have had exposure to significant diagnostic, therapeutic, or employment related radiation within 12 months prior to dosing (serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
* Have participated in a \[¹⁴C\] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous \[¹⁴C\]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1): less than 5000 Milli-rem (mrem) /year whole body annual exposure

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** Covance Clinical Research Unit

**State:** Wisconsin

**Zip:** 53704

#### Overall Officials

**Official 1:**

**Affiliation:** Eli Lilly and Company

**Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** 20 mg [¹⁴C]-LY3337641

**Deaths Num At Risk:** 6

**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** 20 mg [¹⁴C]-LY3337641

**Frequency Threshold:** 5

#### Other Events

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Change of bowel habit

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Ecchymosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Time Frame:** From Baseline to End of Study (Up to 29 Days)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 6

**Units:** Participants

### Group

**ID:** BG000

**Title:** 20mg [¹⁴C]-LY3337641

**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.4

**Value:** 34.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrials.gov@lilly.com
**Organization:** Eli Lilly and Company
**Phone:** 800-545-5979
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.0
- **Upper Limit:** 
- **Value:** 2.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.1
- **Upper Limit:** 
- **Value:** 86.4
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 26
- **Upper Limit:** 
- **Value:** 77.9
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25
- **Upper Limit:** 
- **Value:** 122
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24
- **Upper Limit:** 
- **Value:** 67.5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25
- **Upper Limit:** 
- **Value:** 370
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 51
- **Upper Limit:** 
- **Value:** 1240
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 105
- **Upper Limit:** 
- **Value:** 5840
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants who received the study drug and have evaluable pharmacokinetic (PK) data.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to 22 days
**Title:** Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
**Type:** PRIMARY
**Unit of Measure:** Percentage of total dose
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 2
**Description:** Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to 22 days
**Title:** Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
**Type:** PRIMARY
**Unit of Measure:** Percentage of total dose
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 3
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641
**Type:** SECONDARY
**Unit of Measure:** Nanograms/milliliter (ng/mL)
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 4
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity
**Type:** SECONDARY
**Unit of Measure:** nanogram equivalents/g (ng-equiv/g)
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 5
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 6
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641
**Type:** SECONDARY
**Unit of Measure:** Nanograms*hours per milliliter (ng*h/mL)
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 7
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity
**Type:** SECONDARY
**Unit of Measure:** ng-equivalents*h/gram (ng-equiv*h/g)
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 8
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
**Title:** Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity
**Type:** SECONDARY
**Unit of Measure:** ng*h/mL
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
#### Outcome Measure 9
**Parameter Type:** NUMBER
**Population Description:** All participants who received the study drug and have evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
**Title:** Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces
**Type:** SECONDARY
**Unit of Measure:** Number of Metabolites
##### Group
**Description:** Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** OG000
**Title:** 20 mg [¹⁴C]-LY3337641
### Participant Flow Module
#### Group
**Description:** Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity.
**ID:** FG000
**Title:** 20mg [¹⁴C]-LY3337641
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True