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North of England Hypertension Guideline Development Group (UK). Essential Hypertension: Managing Adult Patients in Primary Care. Newcastle upon Tyne (UK): University of Newcastle upon Tyne; 2004 Aug. (NICE Clinical Guidelines, No. 18.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Essential Hypertension: Managing Adult Patients in Primary Care.

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Appendix 8RCTs of relaxation interventions

TrialComparisonPatient characteristics1. Blinding
2. Randomisation
3. Concealment
4. N
5. Treatment duration
6. Follow-up duration
1. Baseline comparability
2. Age
3. Male%
4. White%
1. Baseline BP
2. CV disease%
3. Diabetes%
1. Total Mortality
2. CHD events
3. Cerebrovascular events
4. Cardiovascular events
5. Blood Pressure
1. Withdrawal
2. Loss to follow-up
Achmon et al, 1989I1: Cognitive group therapy for anger control. Weekly 1½ hour therapist-led group sessions: exercises, role-play, assertive behaviour, instructed to practise methods in real life and keep a daily diary
I2: Heart rate biofeedback. Weekly 1 hour group sessions led by psychology student and cognitive therapist: participants instructed on how to lower heart rate, pulse rate recorded
C: Sham therapy. Attended 2 lectures aimed at stimulating anticipation of BP change, told that monthly BP readings could lower BP, physician available to answer medical questions, free discussion between participants allowed
Israel. Adults, treated or untreated essential hypertension, BP > 140/90, without heart or renal disease, not taking β-blocker, diuretic use allowed but with no dose alteration1. unclear
2. unclear
3. unclear
4. 97
5. 17 weeks
6. 17 weeks
1. yes
2. 40.6; R: 25–60
3. 50.5
4. not reported
1.
I1: 154.0/98.7
I2: 155.0/99.8
C: 155.4/96.1
2. 0
3. not reported
1– 4. not reported
5.
I1: 136.9(13.8)/87.3(8.4), 30
I2: 128.4(12.3)/84.3(9.8), 27
C: 152.4(21.7)/96.9(7.1), 20
1/2.
I1: 10/40 (25.0%)
I2: 10/37 (27.0%)
C: 0/20 (0%)
Adsett et al, 1989I: Relaxation therapy. Weekly one hour therapist-led group sessions: progressive muscle relaxation, information about hypertension, lifestyle & stress
C: Education program. Weekly one hour therapist-led group sessions: information about hypertension, lifestyle & stress
* Factorial design 2x2 with β-blocker and placebo. I and C aggregated over β-blocker and placebo arms
Canada. Currently untreated mildly hypertensive blue-collar workers, mean DBP 90–105; without CVD, CVA, renal disease; researchers tried to ensure medication intake did not vary during study1. blinded assessment
2. adequate
3. unclear
4. 47
5. 8 weeks
6. 3 months
1. yes
2. 46.6
3. 100%
4. not reported
1. 145/96
I1: 144.3/96.2
C: 146.5/96.4
2. 0%
3. 0%
1–4. not reported
5.
I: −16.7(14.7)/−12.1(9.2), 21
C: −15.5(16.)/−9.8(11.9), 23
1/2.
I: 2/23 (8.7%)
C: 1/24 (4.2%)
Agras et al, 1983, Southam et al. 1982I: Relaxation training. Weekly ½ hour therapist led group sessions: tailored instruction in progressive muscular relaxation
C: Ambulatory/in clinic BP measurement only
USA. Adults; DBP > 90, essential hypertension 67% treated hypertensives; unclear whether medication was allowed to vary during study.1. blinded assessment
2. unclear
3. unclear
4. 42
5. 8 weeks + bimonthly booster sessions
6. 17 months
1. unclear
2. 50.7
3. 66.7%
4. not reported
1. 141/95
I: 143.0/98.0
C: 139.9/93.0
2. 0%
3. 0%
1–4. not reported
5.
I: 131.9(16.1)/83.0(10.7), 12
C: 134.8(22.2)/86.8(9.6), 18
1.
I: 3/19 (15.8%)
C: 2/23 (8.7%)
2.
I: 7/19 (37%)
C: 5/23 (22%)
Agras et al, 1987I: Relaxation training: 8 sessions (individual or group). Education about physiology of hypertension, contraction/ relaxation of muscles; provided with relaxation tapes; taught tension-relieving exercises during working day
C: BP monitoring only
USA. Adults, currently treated essential hypertension DBP ≥ 90; unclear whether medication was allowed to vary during study1. unclear
2. unclear
3. unclear
4. 137
5. 10 weeks
6 30 months
1. yes
2. 52.8
3. 81.8%
4. 89.0%
1. 145.8/97.9
I: 146.6/97.1
C: 145.0/98.8
2. 0%
3. 0%
1-4. not reported
5.
I: −9.2(16.8)/−10.1(12.3), 47
C: −8.4(16.5)/−9.8(11.6), 49
1.
I: 0/72 (0%)
2. 0/65 (0%)
I: 25/72 (34.7%)
C: 16/65 (24.6%)
Bennett et al, 1991I1: Type-A management. Weekly 2 hour therapist-led sessions: education, relaxation, cognitive restructuring, meditation, time management, anger control, assertiveness training
I2: Stress management. Weekly 2 hour therapist-led sessions; education, relaxation, cognitive restructuring, meditation; behavioural assignments & diary completion
C: No intervention
* All participants received handout based on British Heart Society booklet: guidance on BP, salt, exercise, stress before intervention
U.K. Adults; currently untreated mildly hypertensive Type A men DBP 90-104
Note. Type A personality: tendency to anger and hostility
1. unclear
2. unclear
3. unclear
4. 47
5. 8 weeks
6. 6 months
1. unclear
2. 46
3. 100%
4. not reported
1. 152/93
I1: 149.2/92.9
I2: 155.9/93.0
C: 151.2/93.5
2. 0%
3. 0%
1-4. not reported
5.
I1: 137.0(12.4)/86.7(6.5), 15
I2: 145.9(14.7)/88.3(8.4), 15
C: 142.3(11.1)/87.9(4.4), 14
1/2.
I1: 1/16 (6.3%)
I2: 2/17 (11.8%)
C: 0/14 (0%)
Brauer, et al, 1979I1: Group relaxation therapy. Therapist-led weekly ½ hour sessions: muscle relaxation, breathing management, meditation; supplemented by 4 tape-recorded lessons
I2: Relaxation therapy with minimal therapist interaction: muscle relaxation, 4 tape-recorded lessons
C: Therapist-led sessions of non-specific psychotherapy for stress & tension
* A behavioural psychiatrist, cardiologist & medical
student acted as therapists treating all three groups
USA. Adults, essential hypertension, treated in previous 6 mths; ≥ 140/90; without CVD, renal disease; unclear whether medication was allowed to vary during study1. blinded assessment
2. unclear
3. unclear
4. 35
5. 10 weeks
6. 6 months
1. unclear
2. 57.2
3. 86.2%
4. not reported
1. 150/93
I1: 153.0/92.7
I2: 150.0/94.8
C: 145.2/93.1
2. 0%
3. 0%
1-4. not reported
5.
I1: −17.8(20.6)/−9.7(15.3), 10
I2: +0.7(15.6)/−4.3(6.1), 9
C: −1.6(15.0)/−1.1(8.7), 10
1. 6/35 (17.1%)
2. 6/35 (17.1%)
Numbers by group not reported
Canino et al, 1994I1: Behavioural programme. Twice-weekly 1¼ hour therapist-led sessions: training in deep- muscle relaxation, biofeedback, anxiety management
C1: placebo treatment – 15 × 75 mins therapist-led sessions; no coping skills strategies training, instructed to record ‘stressful life events’ & relaxation encouraged
C2: No intervention (waiting list)
Venezuela. Adults; SBP > 140 and/or DBP > 90, currently untreated, excluding diabetes, heart/renal disease, 25–48 yrs1. unclear
2. unclear
3. unclear
4. 21
5. 7½ weeks
6. 6 months
1. unclear
2. 35.4 R: 25–46
3. 66.7%
4. not reported
1. 148/97
I1: 147/96
C1: 156/100
C2: 145/97
2. 0%
3. 0%
1–4. not reported
5.
I1: 136.6(6.2)/87.9(5.2), 7
C1: 149.5(3.3)/98.5(3.0), 4
C2: 144.8(8.8)/95.6(7.6), 9
1. not reported
2.
I1: 1
C1: 0
C2: 0
Carson, et al, 1988I: Group relaxation class weekly. Twice daily, ½ hour activity: listening to taped instructions on muscle relaxation
C: Group relaxation class weekly. Twice daily, ½ hour activity: quiet reading of self- selected material
* Both groups were nurse & dietician-led and received education on CHD & CHD risk management
USA. Adults; history of high blood pressure, elevated cholesterol; with CHD. Only 9 had a history of high BP; unclear whether medication was allowed to vary during study1. unclear
2. unclear
3. unclear
4. 16
5. 8 weeks
6. 8 weeks
1. yes
2. 63.5 R: 49–73
3. 100%
4. not reported
1. 140/87
I: 137.0/86.0
C: 142.0/87.0
2. 100%
3. 50%?
1–4. not reported
5.
I: −20.0(20.1)/−11.8(16.2), 8
C: +1.8(16.1)/−1.5(11.1), 8
1. not reported
2. 0
Cottier et al, 1984I: Progressive muscle relaxation. 8×45 minute physician-led individual sessions; taught to practice relaxation during particular situations – telephone calls, at traffic lights, watching television, asked to practice twice daily at home for 20 minutes with the aid of a tape and to keep a diary
C: Control. Blood pressure measured only and attended clinic for physical examination
USA. Adults, treated or untreated borderline-mild hypertension with no more than 2 drugs, untreated clinic BP 140–170/90–115 , home BP > 135/851. open
2. adequate
3. unclear
4. 30
5. 16 weeks
6. 16 weeks
1. yes
2. 34.7; R 18–50
3. 70.0
4. not reported
1. 130/90
I: 130/90
C: 130/90
2. unclear
3. unclear
1–4. not reported
5.
I: 128(SD)/87.5(SD), 17
 −2(4.9))/−2.5(4.1)
C: 131(SD)/92(SD), 9
 +1(4.5)/+2(4.8)
1. 4/30 (13.3%)
2. unclear
Frankel, et al, 1978I1: Biofeedback. 20 therapist-led laboratory sessions of combined DBP & ECG feedback; autogenic training & progressive relaxation exercises; requested to practice exercises at home using tapes
C1: Sham treatment. 20 therapist-led laboratory sessions of sham BP feedback conveying a ‘sense of success’
C2: No intervention
USA. Adults; currently treated & untreated hypertensive patients (mean DBP 90–105) uncomplicated essential hypertension; medication was held constant during the study1. blinded assessment
2. adequate
3. unclear
4. 22
5. 16 weeks
6. 16 weeks
1. unclear
2. 45.8 R: 29–63
3. 54.5%
4. 63.6%
1. 148/95
I1: 148.0/95.0
C1: 150.0/95.0
C2: 147.0/94.0
2. 0%
3. 0%
1–4. not reported
5.
I1: 151.0(16.9)/96.0(7.9), 7
C1: 149.0(18.0)/93.0(5.0), 7
C2: 152.0(13.0)/95.0(3.1), 8
1. not reported
2. 0
Hatch, et al, 1985I1: DBP biofeedback. Twelve 1½ hour therapist- led sessions with verbal praise when DBP was reduced
I2: Progressive deep muscle relaxation. Twelve 1½ hour therapist-led sessions with instruction to tense & relax muscles
C1:Self-directed relaxation Twelve 1½ hour therapist-led sessions; direction on the benefits of relaxation
C2: No behavioural therapy
US adults; currently treated & currently untreated essential hypertensives 140/90 – 180/120; participants instructed to continue to take their medication as usual1. unclear
2. adequate
3 unclear
4. 52
5. 3 months
6. 12 months
1. no, not SBP
2. 51.1 R: 21–70
3. 40.4%
4. 80.7%
1. 138/88*
I1: 134.5/86.7
I2: 147.6/89.4
I3: 136.0/87.2
C: 136.0/87.7
2. 0%
3. 0%
1–4. not reported
5.
I1: 134.6(9.2)/85.0(6.7), 5
I2: 129.3(14.4)/79.0(6.0), 7
I3: 133.7(8.5)/80.0(9.5), 3
C: 125.2(13.2)/82.2(8.1), 5
1. not reported
2.
I1: 8/13 (62%)
I2: 6/13 (46%)
I3: 10/13 (77%)
C: 8/13 (62%)
Hoelscher et al, 1986I1: Individualised relaxation: therapist-led progressive muscle relaxation training sessions
I2: Group relaxation: therapist-led progressive muscle relaxation training sessions
I3: Group relaxation as I2 + behavioural contracts to practise relaxation
C: No intervention (waiting list)
USA. Adults; currently untreated DBP 90–104; without CHD, CVA; participants instructed to continue to take their medication as usual1. unclear
2. unclear
3. unclear
4. 50
5. 4 weeks
6. 10 weeks
1. unclear
2. 51.1
3. 52%
4. not reported
1. 149/96
I1: 152.7/97.3*
I2: 150.3/95.3*
I3: 150.0/95.2*
C: 144.9/96.2*
2. 0%
3. 0%
1–4. not reported
5.
I1: 138.1(13.6)/91.6(9.0), 11
I2: 135.7(9.4)/89.5(6.9), 12
I3: 140.3(10.6)/87.5(5.9), 12
C: 146.9(18.4)/95.6(6.7), 12
1. not reported
2.
I1: 1/12 (8.3%)
I2: 0/0 (0%)
I3: 0/0 (0%)
C: 2/14 (14.3%)
Hoelscher et al, 1987I1: Live progressive relaxation with home relaxation tape. Weekly group sessions, taught muscle tensing & relaxing exercise, instructed to practice at home with a 16 minute recording of progressive relaxation on a tape- player
I2: Live progressive relaxation without home relaxation tape. Weekly group sessions, taught muscle tensing & relaxing exercise, instructed to practice at home with cue cards
C: Waiting list
USA. Adults, treated or untreated essential hypertension ≥1 year, BP ≥140/90, antihypertensive medication not altered in last 3 months1. blinded assessment
2. unclear
3. unclear
4. 48
5. 4 weeks
6. 3 months
1. unclear
2. 51.9
3. not reported
4. not reported
1. 144.8/93.8
I1: 150.8/93.0
I2: 142.7/93.3
C: 141.0/95.0
2. not reported
3. not reported
1–4. not reported
5.
I1: 137.5(11.8)/87.4(7.5), 16
I2: 135.8(13.9)/88.1(5.7), 16
C: 143.3(18.1)/95.2(6.6), 16
1/2. unclear
Irvine et al, 1991I: Biofeedback and relaxation therapy. Behaviour therapist-led weekly ½ hour sessions on hypertension, risks, muscle relaxation, meditation & mental imagery, ‘mini- relaxation’ training, biofeedback
C: Support therapy: behaviour therapist-led weekly sessions
U.K. Adults; mild primary hypertension, untreated in previous 6 mths, DBP 85–104 in age 18–34 or DBP 90–104 in age 35–59 ; without CHD1. blinded assessment
2. unclear
3. unclear
4. 110
5. 12 weeks
6. 6 months
1. yes
2. 46.3 R: 25–64
3. 81.8%
4. not reported
1. 137/94
I: 137.3/94.1
C: 136.4/93.6
2. 0%
3. 0%
1–4. not reported
5.
I: 129.9(10.6)/87.7(4.1) , 47
C: 131.2(10.6)/88.9(5.7) , 48
1.
I: 5/55 (9.1%)
C: 4/55 (7.3%)
2.
I: 8/55 (14.5%)
C: 7/55 (12.7%)
Johnston et al, 1993I: Stress management: ten ½ hour psychologist- led sessions on passive relaxation & meditation
C: Mild exercise: ten ½ hour psychologist-led sessions on simple stretching exercises
USA. Adults; currently untreated mean DBP 95–105, treated BP < 110 without CHD, diabetes, BMI > 1351. single
2. adequate
3. unclear
4. 96
5. 6 months
6. 12 months
1. yes
2. 46.6 R: 23–59
3. 47.9%
4. not reported
1. 138/91
I: 139.8/93.0
C: 140.1/91.9
2. 0%
3. 0%
1–4. not reported
5.
I: 140.9(12.6)/92.9(7.6), 40
C: 134.7(13.0)/90.0(9.6), 32
1.
I: 5/48(10.4%)
C: 7/48(14.6%)
2.
I: 8/48(12.5%)
C: 16/48(33.3%)
Linden, et al, 2001I: Mixed behavioural intervention. Weekly 1 hour sessions led by psychotherapists: autogenic training, thermal biofeedback, cognitive therapy, anxiety management, type- A hostile behaviour reduction, discussion of existential issues
C: No intervention (waiting list)
Canada. Adults; BP > 140/90 currently treated and currently untreated, without CHD, diabetes; asked to maintain usual medication but physician could vary if necessary1. unclear
2. unclear
3. unclear
4. 60
5. 10 weeks
6. 3 months
1. yes
2. 54.8 R: 28–75
3. 71.7%
4. 88.3%
1. 153/98
I: 152.0/97.9
C: 154.1/98.9
2. 0%
3. 0%
1–4. not reported
5.
I: −6.9(12.3)/−5.4(8.9) , 23
C: −5.1(6.8)/−3.7(4.6) , 26
1/2.
I: 4/27 (14.8%)
C: 4/33 (12.1%)
McGrady, 1994I: Group relaxation and feedback. Weekly 45 minute therapist-led sessions providing autogenic relaxation training & thermal biofeedback
C: No intervention (waiting list)
USA. Adults; currently treated and currently untreated essential hypertension patients; medication varied in 37 participants during study (all excluded)1. unclear
2. unclear
3. unclear
4. 138
5. 8 weeks
6. 11 week
1. unclear
2. 48.3
3. 38.6%
4. 75.2%
1. 132/86
I: 132.4/85.8
C: 130.9/85.6
2. 0%
3. 0%
1–4. not reported
5.
I: 126.5(13.7)/82.6(10.4), 70
C: 130.0(12.3)/86.6(10.6), 31
1/2. 37/138 (26.8%)
Withdrawal and loss to follow-up not reported by group. Numbers randomised to each group not reported
Patel, et al, 1981
Patel et al, 1985
I: Group biofeedback and relaxation. Weekly 1 hour sessions: stress education, breathing exercises, deep-muscle relaxation, meditation, biofeedback, provided with tape & requested to practice relaxation at home, health education literature on dietary fats & smoking
C: Control: health education literature on dietary fats & smoking
UK. Adults; mild untreated hypertension: 2/3 of risk factors: mean BP > 140/90; plasma cholesterol >=6.3mmol/l) cigarette smokers1. unclear
2. unclear
3. unclear
4. 204
5. 8 weeks
6. 4 years
1. yes
2. R: 35–64
3. 61.5%
4. not reported
1. 144.7/87.6
I: 145.2/87.4
C: 144.2/87.9
2. 0%
3. 0%
1.
I: 2/107 (1.9%)
C: 2/97 (2.1%)
3. not reported 2& 4.
I: 2/88 (2.3%)
C: 6/81 (27.4%) 5.
I: 139.4(22.4)/85.2(13.6), 86
C: 145.7(21.0)/92.4(12.8), 75
1.
I: 8/107 (7.5%)
C: 4/97 (4.1%)
2.
I: 21/107 (19.6%)
C: 22/97(22.7%)
Patel et al, 1988I: Group relaxation and biofeedback. Weekly physician & nurse-led 1 hour sessions: discussion; breathing exercise, deep muscle relaxation & simple meditation training provided; biofeedback provided; home practice encouraged
C: No intervention
* MRC mild hypertension trial (active drug vs. placebo) substudy: randomised to stop therapy, then further randomised into this trial.
UK. Adults; DBP 90–109, currently treated and currently untreated as determined by allocation in trial, mild hypertension 35–64 yrs1. open
2. adequate
3. adequate
4. 134
5. 8 weeks
6. 1 year
1. no: not BP*
2. 53*
3. 50.5% *
4. not reported
* Assessed in attenders after 1 year
1. 140.1/86.8
I: 144.9/88.6
C: 135.7/85.1
2. 0%
3. 0%
1. I: 1; C: 0
2: I: 0; C: 2
3: I: 1; C: 0
4: I: 1; C: 2
5.
I: −4.9(15.0)/−1.5(8.4), 49
C: +7.1(15.0)/+2.6(8.4), 54
1. 23/134(17.2%)
2. 31/134 (23.1%)
Withdrawal and loss to follow-up not reported by group
Schein et al, 2001I: BIM: ‘breathe with interactive music’. Listening to sounds mimicking breathing patterns, using headphone and respiration sensor.
C: Passive treatment. Listening to quiet synthesised music with non-identifiable rhythm
* Both groups: 10 minutes every evening
Israel. Adults; essential hypertension (currently treated and stabilised and untreated), BP ≥ 140/90, home BP > 135/85; without CHD, CVD, renal disease, diabetes, BMI > 35 kg/m2. It is unclear that drugs were kept constant during the study1. triple
2. adequate
3. unclear
4. 61
5. 8 weeks
6. 8 weeks
1. yes
2. 57.1
3. 47.4%
4. not reported
1. 156/95
I: 156.6/96.7
C: 154.7/93.4
2. 0%
3. 0%
1–4.
not reported
5.
I: −15.2(13.4)/−10.0(6.5), 31
C: −11.3(12.8)/−5.6(6.2), 24
1.
I: 4/32(12%)
C: 5/33(15%)
2.
I: 1/32 (3%)
C: 5/33 (15%)
Seer et al, 1980I: Transcendental meditation. Psychiatrist-led sessions twice daily for 15–20 minutes with mantra recitation
C1: Sham control: psychiatrist-led training twice daily 15–20 minutes without mantra recitation
C2: No intervention (waiting list)
New Zealand. Adults; essential hypertension, currently untreated, without CHD, diabetes, renal disease1. unclear
2. unclear
3. unclear
4. 41
5. 5 weeks
6. 13 weeks
1. unclear
2. 43.2 R: 22–62
3. 56.1%
4. not reported
1. 150/102
I: 152.4/103.6
C1: 147.4/100.1
C2: 149.8/102.2
2. 0%
3. 0%
1–4. not reported
5.
I: −4.8(14.5)/−6.4(11.7), 14
C1: −5.1(9.5)/−7.6(9.6), 14
C2: +1.8(10.7)/+2.2(8.6), 13
1. not reported
2.
I1: 0/14 (0%)
I2: 0/14 (0%)
C: 0/13 (0%)
van Montfrans et al, 1990I: Relaxation therapy: 8, weekly, 1 hour therapist-led sessions on yoga, breathing, posture exercises, meditation & muscle relaxation
C: Non-specific counselling: nurse led sessions encouraging passive relaxation & explaining role of stress in hypertension
Netherlands. Adults; currently untreated SBP 160–200 or DBP 95–110; mild uncomplicated HT, without diabetes, CHD, organ damage1. unclear
2. inadequate
3. inadequate
4. 42
5. 8 weeks
6. 1 year
1. unclear
2. 41.5 R: 24–60
3. 51.4%
4. not reported
1. 154.7/99.8*
I: 153.2/100.7*
C: 156.2/98.9*
2. 0%
3. 0%
1–4. not reported
5.
I: −2.2(7.7)/−2.4(4.7), 18
C: −2.5(6.8)/−3.1(4.9), 17
1/2.
I: 3/23 (13.0%)
C: 2/19 (10.5%)
Zurawski et al, 1987I: Multi-modal stress management training. Weekly 1–11/2 hour therapist-led group sessions: progressive muscular relaxation, role of cognitions in stressful situations and coping strategies, learned cue controlled breathing and relaxation imagery
C: Sham therapy. Weekly 1–11/2 hour therapist-led group sessions: biofeedback training control condition
USA. Adults, treated or untreated essential hypertension, but not excessively overweight, those on medication had their dosage stabilised for ≥ 3 months1. unclear
2. unclear
3. unclear
4. 29
5. 8 weeks
6. 6 months
1. yes
2. 46.9*; R 18–60
3. 27.6*
4. 100
1. 137.5/86.3
I: 137.1/87.1
C: 137.9/85.3
2. unclear
3. unclear
1–4. not reported
5.
I: 129.1(17.5)/80.3(9.5), 14
C: 126.8(14.0)/79.2(8.8), 11
1. 4/29(13.8%)
2.
I: 0
C: 3/11(27.3%)
Crown Copyright © 2004.
Bookshelf ID: NBK45871

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