Study to Investigate Safety, Tolerability, Pharmacodynami... | NCT02424799

NCT02424799

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2014-001015-39	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A: Dose group 1	Experimental	Subjects will be treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 centimetre (cm) on the volar aspect of the arm which approximates to 0.2% total body surface area (BSA), on each arm. On Day 2 and Day 3 subjects will receive active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.	Drug: GSK2646264 0.5% topical cream Drug: Placebo
Part A: Dose group 2	Experimental	Subjects will be treated topically with 1 % GSK2646264 cream and placebo cream on the morning and evening of Day 1 starting at the final % BSA dosed at Day 3 in group 1 which is anticipated to be 5%. In dose group 2, the starting BSA will increase to 10% at Day 3 and then 20% by Day 5. Administration of the evening (PM) dose will be dependent on the data from Part A Dose group 1.	Drug: GSK2646264 0.5% topical cream Drug: GSK2646264 1% topical cream Drug: Placebo
Part B	Experimental	Cold urticaria subjects will receive treatment to 4 defined areas (right and left arms and legs). Subjects will be treated with maximum tolerated strength of GSK2646264 cream (0.5% or 1%) and placebo cream in morning or in morning and evening to 2 specified areas of ~5% BSA on the subject's legs for the CU assessment and to 2 specified areas of 0.2% BSA on the volar aspect of the arm. The maximum tolerated strength and evening dosing will be dependent on the data from the Part A	Drug: GSK2646264 0.5% topical cream Drug: GSK2646264 1% topical cream Drug: Placebo
Part C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK2646264 0.5% topical cream	Drug	GSK2646264 0.5% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars	Part A: Dose group 1 Part A: Dose group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Part A	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment.	Up to Day 7
Number of Participants With AEs and SAEs Part A	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.	Up to Day 11
Number of Participants With AEs and SAEs Part B	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data is presented according to the percentage BSA as it impacted safety	Up to Day 19
Number of Participants With AEs and SAEs Part C	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

Secondary Outcomes

Measure	Description	Time Frame
Plasma GSK2646264 Pharmacokinetic (PK) Concentrations for Part A	Blood samples were collected to assess the plasma concentration of GSK2646264 for Part A on Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (1,2,4,8,12,24 hours) and Day 3 (1,2,4,8,12,24 hours). The actual date and time of each blood sample collection was recorded. PK Population comprised of all randomized participants of the Safety Population for whom a pharmacokinetic sample was obtained and analyzed.

Eligibility Module

Eligibility Criteria

Inclusion criteria for all subjects in Parts A, B and C

Male or female subject aged at least 18 years (Yrs) at the time of signing the informed consent. The upper age limit of subjects is defined in the specific inclusion criteria for each cohort.
All subjects must be free from scarring or skin markings (e.g. tattoos or piercings) and open wounds (e.g. scarring or skin markings) on the defined areas of the body that cream will be applied onto, unless in the opinion of the investigator it will not compromise the subjects safety and quality of data.
Able to refrain from exposure to extended and direct sunlight during the study period, from screening (SCR) until follow up, especially the area that is under treatment during the study.
Able to refrain from shaving and waxing the areas on which the study cream will be applied during the duration of the study from SCR to follow up.
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit or a time period that is 5 terminal half-live post-last dose which will be determined following Part A of the study.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Willing, committed and able to return for all clinic visits and complete all study-related procedures. Able to read, understand and complete study- related questionnaires.

Inclusion criteria specific for healthy subjects (Part A)

The subject is aged between 18 and 55 yrs of age inclusive, at the time of signing the informed consent.
Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19 to 30 kg per square meter (m^2 )(inclusive).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator, in consultation with the GSK Medical Monitor (MM) if required, agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Demonstration of a positive weal and flare reaction (>=3 millimeter (mm) in diameter relative to negative control) to at least one allergen from a battery of allergens (mixed grass pollen, Dermatophagoides pteronyssinus, birch pollen and cat dander) on skin prick testing at SCR.
Subjects must be free from any past or present benign or malignant skin conditions and disease, unless in the opinion of the investigator it will not compromise the subject's safety and quality of data.
Non-smokers or if the subject is a tobacco smoke: smokes less than 5 cigarettes per day and commits to not smoke tobacco for the duration of the in-house stay, and commits to stable and moderate use (as determined by the Investigator) of tobacco or nicotine-containing products, including nicotine patches/gum, during the course of the study, as long as the patches do not interfere with the study procedures.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit [MlU]/milliliter [mL] and estradiol <40 picogram (pg)/mL (<147 picomoles/litre) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods described if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.

Additional Inclusion criteria specific for subjects with CU (Part B)

Diagnosed with CU for more than six weeks as confirmed by medical history and with a positive cold stimulation test assessed by TEMPTest 4.0 prior to first dose.
The subject is aged between 18 and 70 yrs of age inclusive, at the time of signing the informed consent.
Body weight >=50 kg and BMI within the range 19 to 35 kg/m^2 (inclusive).
Other than a diagnosis of CU, the subject should have no other co-morbidities which would introduce additional risk factors and will not interfere with the study procedures, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator, in consultation with the GSK MM if required, agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedure.
In addition, the following criterion will apply to a minimum of 4 patients in Part B: Demonstration of a positive weal and flare reaction (>=3 mm relative to negative control) to at least one allergen from a battery of allergens (mixed grass pollen, Dermatophagoides pteronyssinus, birch pollen and cat dander) on skin prick testing at SCR,
Subjects must be free from any past or present benign or malignant skin conditions and disease, other than the specified condition required for eligibility of subjects as defined in the specific inclusion criteria for CU cohort unless in the opinion of the investigator it will not compromise the subjects safety and quality of data.
Non-smokers or if the subject is a tobacco smoker: smokes less than 5 cigarettes per day and commits to not smoke tobacco for the duration of the in-house stay, and commits to stable and moderate use (as determined by the Investigator) of tobacco or nicotine-containing products, including nicotine patches/gum, during the course of the study, as long as the patches do not interfere with the study procedures.
Female subjects must agree to use one of the contraception methods listed in protocol, 28 days before their SCR visit and until the followup visit or a time period that is 5 terminal half-live post-last dose which will be determined following Part A of the study.

Additional Inclusion criteria specific for subjects with CsU (Part C)

The subject is aged between 18 and 70 yrs of age inclusive, at the time of signing the informed consent.
Body weight >=50 kg and BMI within the range 19 to 35 kg/m2 (inclusive)
Subjects who have a score of >14 on the UAS7 questionnaire with between 4-10 weals observed in a defined area of the body will be included in this study. This area must include either both arms, or both legs or both sides of their torso for 7 consecutive days during the SCR period, prior to the Day 1 visit. If a subject has not completed 7 consecutive days of UAS questionnaire prior to dosing on Day 1 due to exceptional circumstances, the SCR period may be extended until the subject has completed 7 consecutive days of UAS questionnaire. This will only be at the discretion of the Investigator.
No other aetiology identified for chronic urticaria such as drug-related or inducible urticaria as determined by history, physical examination and laboratory studies.
Subjects must be free from any past or present benign or malignant skin conditions and disease, other than the specified condition required for eligibility of subjects as defined in the specific inclusion criteria for CsU cohort unless in the opinion of the investigator it will not compromise the subjects safety and quality of data.
Other than a diagnosis of CsU the subject should have no other co-morbidities which would introduce additional risk factors and will not interfere with the study procedures, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator, in consultation with the GSK MM if required, agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Female subjects must agree to use one of the contraception methods 28 days before their SCR visit listed in protocol and until the follow-up visit or a time period that is 5 terminal half-live post-last dose which will be determined following Part A of the study.

All Cohorts Exclusion Criteria

Thyroid stimulating hormone levels outside normal range.
Subjects with a history of Graves disease.
Subjects with a history of any thyroid cancer.
Unable or unwilling to avoid use of topical creams/lotions at sites where medication will be applied. Washing with soap and water will be permitted.
Based on averaged corrected QT interval for heart rate (Fridericia's) [QTcF] values of triplicate ECGs obtained over a brief recording period: QTcF > 450 msec; or QTcF >480 milliseconds (msec) in subjects with Bundle Branch Block.
Alanine aminotransferase, alkaline phosphatase and bilirubin ≥ 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or previous history of uncomplicated cholecystectomy.
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study medications, or components thereof, history of anaphylaxis or a history of drug or other allergy that, in the opinion of the investigator or GSK MM, contraindicates their participation.
Unable to refrain from vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half lives (whichever is longer) prior to the SCR visit until the completion of the follow-up assessments, unless in the opinion of the Investigator, in consultation with the GSK MM if required, the medication will not interfere with the study procedures or compromise subject safety.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of SCR.
A positive test for HIV antibody.
Lactating females.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Use of topical steroids or calcinurin inhibitors are prohibited during the study from SCR to follow up.
Exclusion related to prior drug treatments: Intake of oral corticosteroids within 7 days >10 milligram (mg) per day prior to first SCR visit; Use of depot corticosteroids within 7 days prior to first SCR visit; Subjects who are taking anticoagulants (e.g. warfarin) must not be on warfarin within 21 days prior to SCR. Subjects who are having psoralen combined with ultraviolet A (PUVA) treatment must not be using PUVA treatment within 21 days prior to SCR.
Subjects who work for the Sponsor, CRO, or one of the study centres. Country Specific Exclusion criteria for Germany that applies to Part A, Part B and Part C.
Subjects who live in detention on court order or on regulatory action, see §40 subsection 1 sentence 3 no. 4 AMG. (Arzneimittelgesetz).

Additional Exclusion for Part A - Healthy Subjects

Use of H1 antihistamines within 3 days prior to first SCR visit Additional Exclusion for Part B - CU Subjects
Exclusion related to prior drug treatments: Use of Zaditen (Ketotifen) within 14 days prior to first SCR visit; Use of Doxepin AZU and other tricyclic antidepressants with antihistaminergic properties within 14 days prior to first SCR visit; Use of H2 antihistamines within 7 days prior to first SCR visit; Use of H1 antihistamines within 7 days prior to first SCR visit; Use of monteleukast or any other leukotriene antagonist within 7 days prior to first SCR visit; Use of biologicals including omalizumab within 5 months prior to first SCR visit.

Additional Exclusion for Part C- CsUpatients

Exclusion related to prior drug treatments: Intake of cyclosporin within 10 days prior to first SCR visit; Intake of other immunosuppressant drugs within 28 days of first SCR visit; Use of monteleukast or any other leukotriene antagonist within 7 days prior to first SCR visit; Use of Dapsone within 7 days prior to first SCR visit; Use of Zaditen (Ketotifen) within 14 days prior to first SCR visit; Use of Doxepin AZU and other tricyclic antidepressants with antihistaminergic properties within 14 days prior to first SCR visit; Use of H2 antihistamines within 7 days prior first SCR visit; Use of biologicals including omalizumab within 5 months prior to first SCR visit; Use of H1 antihistamines above the licensed dose within 3 days prior to first SCR visit.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director
GSK Clinical Trials	GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Berlin		10117	Germany
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34020509	Derived	Dickson MC, Walker A, Grattan C, Perry H, Williams N, Ratia N, Dewit O, Gisbert S, Metz M, Maurer M. Effects of a topical treatment with spleen tyrosine kinase inhibitor in healthy subjects and patients with cold urticaria or chronic spontaneous urticaria: Results of a phase 1a/b randomised double-blind placebo-controlled study. Br J Clin Pharmacol. 2021 Dec;87(12):4797-4808. doi: 10.1111/bcp.14923. Epub 2021 Jun 18.

IPD Sharing Statement Module

No data available

No data is available for this block.

92 participants were screened (3 re-screened) of which 58 were screen failures. Hence 34 participants, 17 healthy participants (Part A), 12 participants with cold urticaria (CU, Part B) and 5 participants with chronic spontaneous urticaria (CsU, Part C) were randomized.

Arm/Group Information

ID	Title	Description
FG000	Part A-GSK2646264 0.5% and Placebo	Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 centimeter (cm) on the volar aspect of the arm which approximated to 0.2% total body surface area (BSA), on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
FG001	Part A-GSK2646264 1% and Placebo	Participants received active treatment (1% cream strength) and placebo on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm and placebo on the other arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso and placebo to the other. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
FG002	Part B-Placebo	CU participants received matching placebo treatment to an area of 10% BSA (5% BSA on each arm, n=1) or 3.5% BSA (spread over the 2 arms, n=2) on Days 1, 2 and 3
FG003	Part B GSK2646264 1%	CU participants received 1% strength GSK2646264 to an area of 10% BSA (5% BSA on each arm, n=3) or 3% BSA (spread over the 2 arms, n=6) on Days 1, 2 and 3
FG004	Part C-Placebo	CSU participants received matching placebo treatment to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
FG005	Part C GSK2646264 1%	CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.

Periods

Title

Milestones

Reasons Not Completed

Part A (Up to Day 11)

Type	Comment	Milestone Data
STARTED		FG0009 subjects FG0018 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects
COMPLETED		FG0009 subjects FG0018 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Part B (Up to Day 19)

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0023 subjects FG003

Part C (Up to Day 23)

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part A-GSK2646264 0.5% and Placebo	Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Part A

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment.

Safety Population

Posted

Count of Participants

Participants

Up to Day 7

ID	Title	Description
OG000	Part A-GSK2646264 0.5%	Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A-GSK2646264 0.5%	Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343		GSKClinicalSupportHD@gsk.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 13, 2016	Jul 2, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 30, 2015	Jul 2, 2018	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D014581	Urticaria

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate

Intervention Browse Module

ID	Term
C000631066	GSK2646264

Masking Info

EG0000 affected9 at risk

EG0012 affected8 at risk

EG0020 affected1 at risk

EG0030 affected3 at risk

EG0040 affected2 at risk

EG0051 affected6 at risk

EG0060 affected1 at risk

EG0070 affected4 at risk

Title	Measurements
	OG0003.0± 7.12

Title	Measurements
	OG000-0.8± 5.50

NA indicates standard deviation could not be calculated as a single participant was analyzed.

Title	Measurements
	OG000-1.1± 9.31

Title	Measurements
	OG0001.8± 9.27

NA indicates standard deviation could not be calculated as a single participant was analyzed.

Title	Measurements
	OG000-0.44± 5.637

Title	Measurements
	OG0000.25± 3.615

NA indicates standard deviation could not be calculated as a single participant was analyzed.

Title	Measurements
	OG0001

Title	Measurements
	OG0001

Title	Measurements
	OG0008

Title	Measurements
	OG0000.00000± 0.00000

Title	Measurements
	OG0000.02780± 0.02780

OG0010.01083± 0.026536

Title	Measurements
	OG00060.2293± 40

Title	Measurements
	OG0003.28320± 34

Title	Measurements
	OG00022.29± 4.158