The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis.
This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
299
A dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese.
To ensure proper blinding, the placebo was formulated to be indistinguishable from Emergen-C in taste, appearance, and other sensory characteristics. The placebo therefore contained fructose, and the electrolytes potassium, magnesium, calcium, and sodium.
Lindus Health Limited
New York, New York, United States
Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
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Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Time frame: Baseline, Weeks 4, 8 and 12