Table 1.

Characteristics of the RCTs Exploring the Role of Subcutaneous Liraglutide Injection for Chronic Weight Management in Adults

StudyParticipant characteristicsNumber randomizedStudy durationResults for liraglutide 3.0 mg vs placeboSide effects for liraglutide 3.0 mg vs placeboAttrition rate
Astrup A et al (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)20 weeksBody weight: −4.4 kg (95% CI, −6.0 to −2.9 kg, P <0.0001); ≥5% body weight loss: 76.1% vs placebo 29.6% (P <0.0001); ≥10% body weight loss: 28.3% vs placebo 2.0%Nausea (47.3% vs 5.1%) Diarrhea (12.9% vs 7.1%) Vomiting (11.8% vs 2.0%) Fatigue (10.8% vs 2.0%) Gastroenteritis (7.5% vs 3.1%)16.3%
Astrup A et al (80) 2-year extension of (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)2 yearsBody weight: −5.8 kg (95% CI, −8.0 to −3.7 kg, P0.001); ≥5% body weight loss: 73% vs placebo 28% (P ≤0.001); ≥10% body weight loss: 37% vs placebo 10% (P ≤0.001).Nausea (48.4% vs 7.1%) Gastroenteritis (23.7% vs 13.3%) Influenza (23.7% vs 10.2%) Constipation (18.3% vs 12.2%) Diarrhea (15.1% vs 10.2%) URI (14.0% vs 9.2%) Fatigue (14.0% vs 8.2%) Vomiting (12.9% vs 2.0%)23.8%
Wadden et al (81) SCALE Maintenance81% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertension, loss ≥5 % of the initial body weight in low caloric diet run-in period (4-12 weeks)Liraglutide 3.0 mg (N = 212) Placebo (N = 210)56 weeksBody weight: −5.9 kg (95% CI, −7.3 to −4.4 kg, P <0.0001); Body weight: −6.1 % (95% CI, −7.5 to −4.6%, P <0.0001); ≥5% body weight loss: 50.5% vs placebo 21.8% (P <0.0001); ≥10% body weight loss: 26.1% vs placebo 6.3% (P <0.0001); maintenance of ≥5% run-in weight loss: 81.4% vs placebo 48.9% (P <0.0001).Nausea (47.6% vs 17.1%) Constipation (26.9% vs 12.4%) Diarrhea (17.9% vs 12.4%) Vomiting (16.5% vs 2.4%) Decreased appetite (9.9% vs 1.4%) Dyspepsia (9.4% vs 1.9%) Fatigue (8.0% vs 5.2%) Abdominal pain (6.6% vs 1.4%) Hypoglycemia (5.2% vs 2.4%)27.7%
Pi-Sunyer et al (82) SCALE Obesity and prediabetes 78% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertensionLiraglutide 3.0 mg (N = 2487) Placebo (N = 1244)56 weeksBody weight: −5.6 kg (95% CI, −6.0 to −5.1 kg, P <0.0001); Body weight: −5.4% (95% CI, −5.8 to −5.0%, P <0.001); ≥5% body weight loss: 63.2% vs placebo 27.1% (P <0.001); ≥10% body weight loss: 33.1% vs placebo 10.6% (P <0.001).Nausea (40.2% vs 14.7%) Diarrhea (20.9% vs 9.3%) Constipation (20.0% vs 8.7%) Vomiting (16.3% vs 4.1%) Decreased appetite (10.8% vs 3.1%) Dyspepsia (9.5% vs 3.1%)30.6%
Davies et al (83) SCALE Diabetes50% women, stable body weight, BMI ≥27 kg/m2, type 2 diabetes (HbA1c 7.0%-10.0%) treated with diet and exercise alone or in combination with 1-3 oral glucose- lowering agentsLiraglutide 3.0 mg (N = 423) Liraglutide 1.8 mg (N = 211) Placebo (N = 212)56 weeksBody weight: −4.2 kg; Body weight: −4.0 % (95% CI, −5.1 to −2.9%, P <0.001); ≥5% body weight loss: 54.3% vs placebo 21.4% (P <0.001); ≥10% body weight loss: 25.2% vs placebo 6.7% (P <0.001).Hypoglycemiaa (44.5% vs 27.4%) Nausea (32.7% vs 13.7%) Diarrhea (25.6% vs 12.7%) Constipation (16.1% vs 6.1%) Vomiting (15.6% vs 5.7%) Dyspepsia (11.1% vs 2.4%) Abdominal distension (6.2% vs 1.4%) Abdominal pain (6.2% vs 4.2%) 25.8%
Blackman et al (84) SCALE Sleep Apnea28% women, stable body weight, BMI ≥30 kg/m2, moderate to severe OSA, unwilling or unable to use CPAPLiraglutide 3.0 mg (N = 180) Placebo (N = 179)32 weeksBody weight: −4.9 kg (95% CI, −6.2 to −3.7 kg, P < 0.0001); Body weight: −4.2 % (95% CI, −5.2 to −3.1%, P <0.0001); ≥5% body weight loss: 46.4% vs placebo 18.1% (P <0.0001); ≥10% body weight loss: 22.4% vs placebo 1.5% (P <0.0001).Nausea (26.7% vs 6.7%) Diarrhea (16.5% vs 7.8%) Constipation (11.9% vs 3.4%) Dyspepsia (8.5% vs0.1.1%) Vomiting (7.4% vs 2.8%) GERD (5.7% vs 0.6%)23.1%
StudyParticipant characteristicsNumber randomizedStudy durationResults for liraglutide 3.0 mg vs placeboSide effects for liraglutide 3.0 mg vs placeboAttrition rate
Astrup A et al (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)20 weeksBody weight: −4.4 kg (95% CI, −6.0 to −2.9 kg, P <0.0001); ≥5% body weight loss: 76.1% vs placebo 29.6% (P <0.0001); ≥10% body weight loss: 28.3% vs placebo 2.0%Nausea (47.3% vs 5.1%) Diarrhea (12.9% vs 7.1%) Vomiting (11.8% vs 2.0%) Fatigue (10.8% vs 2.0%) Gastroenteritis (7.5% vs 3.1%)16.3%
Astrup A et al (80) 2-year extension of (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)2 yearsBody weight: −5.8 kg (95% CI, −8.0 to −3.7 kg, P0.001); ≥5% body weight loss: 73% vs placebo 28% (P ≤0.001); ≥10% body weight loss: 37% vs placebo 10% (P ≤0.001).Nausea (48.4% vs 7.1%) Gastroenteritis (23.7% vs 13.3%) Influenza (23.7% vs 10.2%) Constipation (18.3% vs 12.2%) Diarrhea (15.1% vs 10.2%) URI (14.0% vs 9.2%) Fatigue (14.0% vs 8.2%) Vomiting (12.9% vs 2.0%)23.8%
Wadden et al (81) SCALE Maintenance81% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertension, loss ≥5 % of the initial body weight in low caloric diet run-in period (4-12 weeks)Liraglutide 3.0 mg (N = 212) Placebo (N = 210)56 weeksBody weight: −5.9 kg (95% CI, −7.3 to −4.4 kg, P <0.0001); Body weight: −6.1 % (95% CI, −7.5 to −4.6%, P <0.0001); ≥5% body weight loss: 50.5% vs placebo 21.8% (P <0.0001); ≥10% body weight loss: 26.1% vs placebo 6.3% (P <0.0001); maintenance of ≥5% run-in weight loss: 81.4% vs placebo 48.9% (P <0.0001).Nausea (47.6% vs 17.1%) Constipation (26.9% vs 12.4%) Diarrhea (17.9% vs 12.4%) Vomiting (16.5% vs 2.4%) Decreased appetite (9.9% vs 1.4%) Dyspepsia (9.4% vs 1.9%) Fatigue (8.0% vs 5.2%) Abdominal pain (6.6% vs 1.4%) Hypoglycemia (5.2% vs 2.4%)27.7%
Pi-Sunyer et al (82) SCALE Obesity and prediabetes 78% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertensionLiraglutide 3.0 mg (N = 2487) Placebo (N = 1244)56 weeksBody weight: −5.6 kg (95% CI, −6.0 to −5.1 kg, P <0.0001); Body weight: −5.4% (95% CI, −5.8 to −5.0%, P <0.001); ≥5% body weight loss: 63.2% vs placebo 27.1% (P <0.001); ≥10% body weight loss: 33.1% vs placebo 10.6% (P <0.001).Nausea (40.2% vs 14.7%) Diarrhea (20.9% vs 9.3%) Constipation (20.0% vs 8.7%) Vomiting (16.3% vs 4.1%) Decreased appetite (10.8% vs 3.1%) Dyspepsia (9.5% vs 3.1%)30.6%
Davies et al (83) SCALE Diabetes50% women, stable body weight, BMI ≥27 kg/m2, type 2 diabetes (HbA1c 7.0%-10.0%) treated with diet and exercise alone or in combination with 1-3 oral glucose- lowering agentsLiraglutide 3.0 mg (N = 423) Liraglutide 1.8 mg (N = 211) Placebo (N = 212)56 weeksBody weight: −4.2 kg; Body weight: −4.0 % (95% CI, −5.1 to −2.9%, P <0.001); ≥5% body weight loss: 54.3% vs placebo 21.4% (P <0.001); ≥10% body weight loss: 25.2% vs placebo 6.7% (P <0.001).Hypoglycemiaa (44.5% vs 27.4%) Nausea (32.7% vs 13.7%) Diarrhea (25.6% vs 12.7%) Constipation (16.1% vs 6.1%) Vomiting (15.6% vs 5.7%) Dyspepsia (11.1% vs 2.4%) Abdominal distension (6.2% vs 1.4%) Abdominal pain (6.2% vs 4.2%) 25.8%
Blackman et al (84) SCALE Sleep Apnea28% women, stable body weight, BMI ≥30 kg/m2, moderate to severe OSA, unwilling or unable to use CPAPLiraglutide 3.0 mg (N = 180) Placebo (N = 179)32 weeksBody weight: −4.9 kg (95% CI, −6.2 to −3.7 kg, P < 0.0001); Body weight: −4.2 % (95% CI, −5.2 to −3.1%, P <0.0001); ≥5% body weight loss: 46.4% vs placebo 18.1% (P <0.0001); ≥10% body weight loss: 22.4% vs placebo 1.5% (P <0.0001).Nausea (26.7% vs 6.7%) Diarrhea (16.5% vs 7.8%) Constipation (11.9% vs 3.4%) Dyspepsia (8.5% vs0.1.1%) Vomiting (7.4% vs 2.8%) GERD (5.7% vs 0.6%)23.1%

aAmerican Diabetes Association definition.

Abbreviations: BMI, body mass index; CPAP, continuous positive airway pressure; GERD, gastroesophageal reflux disease OSA, obstructive sleep apnea; RCT, randomized controlled trial; URI, upper respiratory tract infection.

Table 1.

Characteristics of the RCTs Exploring the Role of Subcutaneous Liraglutide Injection for Chronic Weight Management in Adults

StudyParticipant characteristicsNumber randomizedStudy durationResults for liraglutide 3.0 mg vs placeboSide effects for liraglutide 3.0 mg vs placeboAttrition rate
Astrup A et al (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)20 weeksBody weight: −4.4 kg (95% CI, −6.0 to −2.9 kg, P <0.0001); ≥5% body weight loss: 76.1% vs placebo 29.6% (P <0.0001); ≥10% body weight loss: 28.3% vs placebo 2.0%Nausea (47.3% vs 5.1%) Diarrhea (12.9% vs 7.1%) Vomiting (11.8% vs 2.0%) Fatigue (10.8% vs 2.0%) Gastroenteritis (7.5% vs 3.1%)16.3%
Astrup A et al (80) 2-year extension of (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)2 yearsBody weight: −5.8 kg (95% CI, −8.0 to −3.7 kg, P0.001); ≥5% body weight loss: 73% vs placebo 28% (P ≤0.001); ≥10% body weight loss: 37% vs placebo 10% (P ≤0.001).Nausea (48.4% vs 7.1%) Gastroenteritis (23.7% vs 13.3%) Influenza (23.7% vs 10.2%) Constipation (18.3% vs 12.2%) Diarrhea (15.1% vs 10.2%) URI (14.0% vs 9.2%) Fatigue (14.0% vs 8.2%) Vomiting (12.9% vs 2.0%)23.8%
Wadden et al (81) SCALE Maintenance81% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertension, loss ≥5 % of the initial body weight in low caloric diet run-in period (4-12 weeks)Liraglutide 3.0 mg (N = 212) Placebo (N = 210)56 weeksBody weight: −5.9 kg (95% CI, −7.3 to −4.4 kg, P <0.0001); Body weight: −6.1 % (95% CI, −7.5 to −4.6%, P <0.0001); ≥5% body weight loss: 50.5% vs placebo 21.8% (P <0.0001); ≥10% body weight loss: 26.1% vs placebo 6.3% (P <0.0001); maintenance of ≥5% run-in weight loss: 81.4% vs placebo 48.9% (P <0.0001).Nausea (47.6% vs 17.1%) Constipation (26.9% vs 12.4%) Diarrhea (17.9% vs 12.4%) Vomiting (16.5% vs 2.4%) Decreased appetite (9.9% vs 1.4%) Dyspepsia (9.4% vs 1.9%) Fatigue (8.0% vs 5.2%) Abdominal pain (6.6% vs 1.4%) Hypoglycemia (5.2% vs 2.4%)27.7%
Pi-Sunyer et al (82) SCALE Obesity and prediabetes 78% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertensionLiraglutide 3.0 mg (N = 2487) Placebo (N = 1244)56 weeksBody weight: −5.6 kg (95% CI, −6.0 to −5.1 kg, P <0.0001); Body weight: −5.4% (95% CI, −5.8 to −5.0%, P <0.001); ≥5% body weight loss: 63.2% vs placebo 27.1% (P <0.001); ≥10% body weight loss: 33.1% vs placebo 10.6% (P <0.001).Nausea (40.2% vs 14.7%) Diarrhea (20.9% vs 9.3%) Constipation (20.0% vs 8.7%) Vomiting (16.3% vs 4.1%) Decreased appetite (10.8% vs 3.1%) Dyspepsia (9.5% vs 3.1%)30.6%
Davies et al (83) SCALE Diabetes50% women, stable body weight, BMI ≥27 kg/m2, type 2 diabetes (HbA1c 7.0%-10.0%) treated with diet and exercise alone or in combination with 1-3 oral glucose- lowering agentsLiraglutide 3.0 mg (N = 423) Liraglutide 1.8 mg (N = 211) Placebo (N = 212)56 weeksBody weight: −4.2 kg; Body weight: −4.0 % (95% CI, −5.1 to −2.9%, P <0.001); ≥5% body weight loss: 54.3% vs placebo 21.4% (P <0.001); ≥10% body weight loss: 25.2% vs placebo 6.7% (P <0.001).Hypoglycemiaa (44.5% vs 27.4%) Nausea (32.7% vs 13.7%) Diarrhea (25.6% vs 12.7%) Constipation (16.1% vs 6.1%) Vomiting (15.6% vs 5.7%) Dyspepsia (11.1% vs 2.4%) Abdominal distension (6.2% vs 1.4%) Abdominal pain (6.2% vs 4.2%) 25.8%
Blackman et al (84) SCALE Sleep Apnea28% women, stable body weight, BMI ≥30 kg/m2, moderate to severe OSA, unwilling or unable to use CPAPLiraglutide 3.0 mg (N = 180) Placebo (N = 179)32 weeksBody weight: −4.9 kg (95% CI, −6.2 to −3.7 kg, P < 0.0001); Body weight: −4.2 % (95% CI, −5.2 to −3.1%, P <0.0001); ≥5% body weight loss: 46.4% vs placebo 18.1% (P <0.0001); ≥10% body weight loss: 22.4% vs placebo 1.5% (P <0.0001).Nausea (26.7% vs 6.7%) Diarrhea (16.5% vs 7.8%) Constipation (11.9% vs 3.4%) Dyspepsia (8.5% vs0.1.1%) Vomiting (7.4% vs 2.8%) GERD (5.7% vs 0.6%)23.1%
StudyParticipant characteristicsNumber randomizedStudy durationResults for liraglutide 3.0 mg vs placeboSide effects for liraglutide 3.0 mg vs placeboAttrition rate
Astrup A et al (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)20 weeksBody weight: −4.4 kg (95% CI, −6.0 to −2.9 kg, P <0.0001); ≥5% body weight loss: 76.1% vs placebo 29.6% (P <0.0001); ≥10% body weight loss: 28.3% vs placebo 2.0%Nausea (47.3% vs 5.1%) Diarrhea (12.9% vs 7.1%) Vomiting (11.8% vs 2.0%) Fatigue (10.8% vs 2.0%) Gastroenteritis (7.5% vs 3.1%)16.3%
Astrup A et al (80) 2-year extension of (79)76% women stable body weight, BMI ≥30 kg/m2 and ≤40 kg/m2Liraglutide 1.2 mg (N = 95) Liraglutide 1.8 mg (N = 90) Liraglutide 2.4 mg (N = 93) Liraglutide 3.0 mg (N = 93) Orlistat (N = 95) Placebo (N = 98)2 yearsBody weight: −5.8 kg (95% CI, −8.0 to −3.7 kg, P0.001); ≥5% body weight loss: 73% vs placebo 28% (P ≤0.001); ≥10% body weight loss: 37% vs placebo 10% (P ≤0.001).Nausea (48.4% vs 7.1%) Gastroenteritis (23.7% vs 13.3%) Influenza (23.7% vs 10.2%) Constipation (18.3% vs 12.2%) Diarrhea (15.1% vs 10.2%) URI (14.0% vs 9.2%) Fatigue (14.0% vs 8.2%) Vomiting (12.9% vs 2.0%)23.8%
Wadden et al (81) SCALE Maintenance81% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertension, loss ≥5 % of the initial body weight in low caloric diet run-in period (4-12 weeks)Liraglutide 3.0 mg (N = 212) Placebo (N = 210)56 weeksBody weight: −5.9 kg (95% CI, −7.3 to −4.4 kg, P <0.0001); Body weight: −6.1 % (95% CI, −7.5 to −4.6%, P <0.0001); ≥5% body weight loss: 50.5% vs placebo 21.8% (P <0.0001); ≥10% body weight loss: 26.1% vs placebo 6.3% (P <0.0001); maintenance of ≥5% run-in weight loss: 81.4% vs placebo 48.9% (P <0.0001).Nausea (47.6% vs 17.1%) Constipation (26.9% vs 12.4%) Diarrhea (17.9% vs 12.4%) Vomiting (16.5% vs 2.4%) Decreased appetite (9.9% vs 1.4%) Dyspepsia (9.4% vs 1.9%) Fatigue (8.0% vs 5.2%) Abdominal pain (6.6% vs 1.4%) Hypoglycemia (5.2% vs 2.4%)27.7%
Pi-Sunyer et al (82) SCALE Obesity and prediabetes 78% women, stable body weight, BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidemia or hypertensionLiraglutide 3.0 mg (N = 2487) Placebo (N = 1244)56 weeksBody weight: −5.6 kg (95% CI, −6.0 to −5.1 kg, P <0.0001); Body weight: −5.4% (95% CI, −5.8 to −5.0%, P <0.001); ≥5% body weight loss: 63.2% vs placebo 27.1% (P <0.001); ≥10% body weight loss: 33.1% vs placebo 10.6% (P <0.001).Nausea (40.2% vs 14.7%) Diarrhea (20.9% vs 9.3%) Constipation (20.0% vs 8.7%) Vomiting (16.3% vs 4.1%) Decreased appetite (10.8% vs 3.1%) Dyspepsia (9.5% vs 3.1%)30.6%
Davies et al (83) SCALE Diabetes50% women, stable body weight, BMI ≥27 kg/m2, type 2 diabetes (HbA1c 7.0%-10.0%) treated with diet and exercise alone or in combination with 1-3 oral glucose- lowering agentsLiraglutide 3.0 mg (N = 423) Liraglutide 1.8 mg (N = 211) Placebo (N = 212)56 weeksBody weight: −4.2 kg; Body weight: −4.0 % (95% CI, −5.1 to −2.9%, P <0.001); ≥5% body weight loss: 54.3% vs placebo 21.4% (P <0.001); ≥10% body weight loss: 25.2% vs placebo 6.7% (P <0.001).Hypoglycemiaa (44.5% vs 27.4%) Nausea (32.7% vs 13.7%) Diarrhea (25.6% vs 12.7%) Constipation (16.1% vs 6.1%) Vomiting (15.6% vs 5.7%) Dyspepsia (11.1% vs 2.4%) Abdominal distension (6.2% vs 1.4%) Abdominal pain (6.2% vs 4.2%) 25.8%
Blackman et al (84) SCALE Sleep Apnea28% women, stable body weight, BMI ≥30 kg/m2, moderate to severe OSA, unwilling or unable to use CPAPLiraglutide 3.0 mg (N = 180) Placebo (N = 179)32 weeksBody weight: −4.9 kg (95% CI, −6.2 to −3.7 kg, P < 0.0001); Body weight: −4.2 % (95% CI, −5.2 to −3.1%, P <0.0001); ≥5% body weight loss: 46.4% vs placebo 18.1% (P <0.0001); ≥10% body weight loss: 22.4% vs placebo 1.5% (P <0.0001).Nausea (26.7% vs 6.7%) Diarrhea (16.5% vs 7.8%) Constipation (11.9% vs 3.4%) Dyspepsia (8.5% vs0.1.1%) Vomiting (7.4% vs 2.8%) GERD (5.7% vs 0.6%)23.1%

aAmerican Diabetes Association definition.

Abbreviations: BMI, body mass index; CPAP, continuous positive airway pressure; GERD, gastroesophageal reflux disease OSA, obstructive sleep apnea; RCT, randomized controlled trial; URI, upper respiratory tract infection.

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