Trial Outcomes & Findings for Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation (NCT NCT04556136)

NCT ID: NCT04556136

Last Updated: 2024-03-13

Results Overview

25 Hydroxyvitamin D level in the blood

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

10 weeks

Results posted on

2024-03-13

Participant Flow

Recruiting efforts attempted to capture a representative sample of the population including both genders, diverse ethnicities, and a range of age (18-70 years) and BMI, who have no contraindication for UVB exposure or oral vitamin D supplementation. In addition to walk-in volunteers who read medical center flyers or social media posts, or were informed through word-of-mouth, the team attended the military base Newcomer's Orientation monthly. Recruitment period 8 months.

No pre-assignment activities.

Participant milestones

Participant milestones
Measure	Standing Phototherapy Kiosk (SPK) Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Overall Study STARTED	53	53
Overall Study COMPLETED	43	45
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Standing Phototherapy Kiosk (SPK) Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Overall Study Lost to Follow-up	6	6
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 10 weeks

Population: Final sample included 43 in SPK and 45 in Oral Supplement group; 10 subjects of 98 enrolled dropped out prior to the end of the study.

25 Hydroxyvitamin D level in the blood

Outcome measures

Outcome measures
Measure	Standing Phototherapy Kiosk (SPK) n=43 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement n=45 Participants Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Serum Vitamin D Level	30.0 ng/mL Interval 25.8 to 37.0	25.5 ng/mL Interval 21.0 to 29.8

PRIMARY outcome

Timeframe: Baseline and 14 weeks

Population: Final sample included 43 in SPK group and 45 in Oral supplement group; 10 of 98 dropped out

Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group.

Outcome measures

Outcome measures
Measure	Standing Phototherapy Kiosk (SPK) n=43 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement n=45 Participants Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Change in Serum Vitamin D Level From Baseline to Week 14	27 ng/mL Interval 22.0 to 32.5	21 ng/mL Interval 17.0 to 30.0

PRIMARY outcome

Timeframe: 10 weeks

Population: Intent-to-treat analysis used to assess number consuming all of the Oral supplement and the number receiving all 6 phototherapy (SPK) treatments.

Percentage of participants with adherence to daily supplement, and Percentage of phototherapy treatments received. Adherence to daily supplement was calculated as the percentage of participants who consumed all 70 pills. Adherence to phototherapy treatments was calculated as the percentage of participants who received all 6 treatments according to protocol.

Outcome measures

Outcome measures
Measure	Standing Phototherapy Kiosk (SPK) n=43 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement n=45 Participants Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Percentage of Participants With Adherence	98 percentage of participants	98 percentage of participants

SECONDARY outcome

Timeframe: 14 weeks

Population: Only the SPK group was asked about acceptability and satisfaction with the kiosk.

User acceptability and satisfaction with the novel kiosk on the Device Usability Scale (DUS), also referred to as System Usability Scale. The DUS was administered to the SPK Group upon completion of the study to assess user acceptability of the intervention. This 12-item Likert-type scale assessed cleanliness, ease of use, and comfort of the kiosk with a Likert-type scale where 1= Strongly disagree to 5 = Strongly agree. Minimum score = 12, maximum score = 60. Higher scores indicate greater acceptability and satisfaction with the device.

Outcome measures

Outcome measures
Measure	Standing Phototherapy Kiosk (SPK) n=43 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Device Acceptability Using Device Usability Scale	55.38 score on a scale Standard Deviation 4.33	—

SECONDARY outcome

Timeframe: Baseline to 14 weeks

Population: Subject retention at the 14-week measurement point

We examined the number of subjects remaining at 14 weeks.

Outcome measures

Outcome measures
Measure	Standing Phototherapy Kiosk (SPK) n=39 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement n=41 Participants Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
Number of Subjects Retained at 14 Weeks	39 Participants	41 Participants

Adverse Events

Standing Phototherapy Kiosk (SPK)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary McCarthy

Madigan Army Medical Center

Phone: 253-968-3695

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standing Phototherapy Kiosk (SPK) n=53 Participants Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.	Oral Supplement n=53 Participants Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=106 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=53 Participants	49 Participants n=53 Participants	101 Participants n=106 Participants
Age, Categorical >=65 years	1 Participants n=53 Participants	4 Participants n=53 Participants	5 Participants n=106 Participants
Sex: Female, Male Female	32 Participants n=43 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.	25 Participants n=45 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.	57 Participants n=88 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.
Sex: Female, Male Male	11 Participants n=43 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.	20 Participants n=45 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.	31 Participants n=88 Participants • Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group.
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=43 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	8 Participants n=45 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	15 Participants n=88 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=43 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	37 Participants n=45 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	73 Participants n=88 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=43 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	0 Participants n=45 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.	0 Participants n=88 Participants • Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) Asian	0 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	0 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) Black or African American	5 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	7 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	12 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) White	27 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	20 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	47 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) More than one race	7 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	8 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	15 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=43 Participants • Due to attrition, the number analyzed is different from the number enrolled.	10 Participants n=45 Participants • Due to attrition, the number analyzed is different from the number enrolled.	14 Participants n=88 Participants • Due to attrition, the number analyzed is different from the number enrolled.
Region of Enrollment United States	43 participants n=43 Participants • Due to attrition, the number analyzed differs from the number enrolled.	45 participants n=45 Participants • Due to attrition, the number analyzed differs from the number enrolled.	88 participants n=88 Participants • Due to attrition, the number analyzed differs from the number enrolled.
Marital status Single	8 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.	12 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.	20 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.
Marital status Married	35 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.	33 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.	68 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolled.
Military affiliation Active duty	22 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	28 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	50 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.
Military affiliation Retired or prior service	11 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	8 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	19 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.
Military affiliation Family member	8 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	6 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	14 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.
Military affiliation None	2 Participants n=43 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	3 Participants n=45 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.	5 Participants n=88 Participants • Due to attrition, the number of subjects analyzed differs from the number enrolle.