An Examination of a Weight Loss Formula on Health

Study Overview
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Brief Summary
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The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Detailed Description
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Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Official Title
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An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Active with caffeine
* Dietary Supplement: Active without caffeine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) between 25 and 34.9 Exclusion Criteria: Recent history of weight change (+/- 10 lbs. within the past 3 months) Uncontrolled metabolic disorders Uncontrolled cardiovascular disorders Currently taking prescription medications (birth control is allowed) Currently taking dietary supplements for weight loss Pregnant or plan to become pregnant Have an intolerance to caffeine or other natural stimulants

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active with caffeine<br>Novel formula with caffeine | Dietary Supplement: Active with caffeine<br>* Novel formula with caffeine<br>|
| Active Comparator: Active without caffeine<br>Novel formula without caffeine | Dietary Supplement: Active without caffeine<br>* Novel formula without caffeine<br>|
| Placebo Comparator: Placebo<br>Dextrose | Dietary Supplement: Placebo<br>* Dextrose placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition - Weight | Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Body Composition - Fat Mass | Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Body Composition - Body Fat Percent | Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition - Lean Tissue Mass | Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Body Composition - Bone Mass | Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Body Composition - Fat Free Mass | Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Body Composition - Total Body Water | Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Resting Energy Expenditure - Caloric Expenditure | Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Resting Energy Expenditure - Respiratory Exchange Ratio | Change in resting respiratory exchange ratio (RER) as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Anthropometric Measures - Waist Circumference | Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Anthropometric Measures - Hip Circumference | Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Anthropometric Measures - Waist to Hip Ratio | Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Anthropometric Measures - Body Mass Index | Change in body mass index (kg of body mass / height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Dietary Energy Intake - Total Caloric Intake | Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Dietary Energy Intake - Carbohydrate | Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Dietary Energy Intake - Fat | Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Dietary Energy Intake - Protein | Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Resting Hemodynamics - Heart Rate | Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Resting Hemodynamics - Systolic Blood Pressure | Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Resting Hemodynamics - Diastolic Blood Pressure | Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose | Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin | Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance | Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Lipid Profile - Triglyderides | Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol | Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins | Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins | Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio | Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Creatinine | Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen | Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio | Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase | Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase | Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase | Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase | Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase | Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells | Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes | Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count | Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte | Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells | Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin | Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit | Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume | Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin | Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration | Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width | Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count | Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume | Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Blood Chemistry Markers of Health - Appetite Hormone - Leptin | Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| International Physical Activity Questionnaire (IPAQ) - Work Domain | Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain | Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain | Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain | Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score | Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Satiety Questionnaire - Perceptions of Appetite | Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Satiety Questionnaire - Perceptions of Hunger | Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Satiety Questionnaire - Perceptions of Satisfaction with Food | Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Satiety Questionnaire - Perceptions of Feelings of Fullness | Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction | Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Sleep Quality Questionnaire - Sleep Duration | Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Sleep Quality Questionnaire - Sleep Quality | Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Sleep Quality Questionnaire - Enthusiasm | Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Sleep Quality Questionnaire - Sleep Disturbances | Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Dizziness | Change in perceptions of dizziness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Headache | Change in perceptions of headache using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Tachycardia | Change in perceptions of tachycardia using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Palpitations | Change in perceptions of palpitations using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Dyspnea | Change in perceptions of dyspnea using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Nervousness | Change in perceptions of nervousness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Blurred Vision | Change in perceptions of blurred vision using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks | 
| Perceptions of Side Effects - Other Side Effects | Change in perceptions of other side effects using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's). | Measured every 4 weeks for 12 weeks |