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123Study details 1 Study Design Setting ED ScaleAgeMean(SD)RangeComorbiditySerumLevelsTest timeCut-off(T)Normalrange(T)AssayJohnson 1992 Prospective Urology clinic NR NR NRTT, PRL,LHNR<3 ng/dl2.2–7.7ng/dlRIAEl-Sakka2005ProspectiveEndocrinologyclinicIIEFEndocrinopathy (297)-51.9 ±12.2Noendocrinopathy (951)-52.3 ±11.7Obesity, diabetes,hypertension,ischemic heartdisease,dyslipidemia,CerebrovasularstrokeTT, PRL,LH, FSHmorning<2.8 ng/mL(3x)2.8–8.8ng/mLECLATsujimura2005ProspectiveSexualfunction clinicAMS,IIEF–556(median)50–79NRTT,LH, FSH,PRLMorning09:00–11:00<3.7 ng/mL(11nmol/L)2.7–10.7ng/mlRIAGuay 1991ProspectiveEndocrinologyclinic– NR NRTT, LH,FSHmorningNRTT >3ng/mLFT 50–200pg/mLRIAForsberg1990ProspectiveDepartment ofurology andclinic forsexualtherapyNR47(median)Vascular disease,DMTT. LH,FSH,PRLsame timeof dayLow <10nmol/LBorderline10–15nmol/LNRNRReyes-Vallejo2006Prospective NR NR 55.230–79Hypercholesterolemia,DM,hypertension,CAD, depressionTT, FT,FSH, LH,PRLNR <3 ng/mL NR ECLAEl-Sakka2006ProspectiveAndrologyclinicIIEF53.9 ±8.526–86overweight, DM,hypertension, IHD,dyslipidemia,TT, PRLmorning<2.8 ng/mL(3x)2.8–8.8ng/mLECLA
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This report is based on research co
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This document is in the public doma
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AcknowledgmentsThe authors would li
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ContentsExecutive Summary..........
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Table 17: Intra-urethral Treatment:
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Figure 63. Absolute Mean Change Fro
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associated with ED treatments. Two
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ED as a main complaint. In only one
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different formulations/modes of app
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Evidence Report
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flaccidity are no less important th
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prostatectomy, antipsychotic agents
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disease). Furthermore, there is ins
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Analytic FrameworkFigure 1. Analyti
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KQ 3. Harms of pharmaceutical treat
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Figure 2. Modified QUOROM Flow Char
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that included intervention characte
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Prevalence of Hypogonadism (Total S
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stimulation and a challenge test wi
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Overview of Trials79-84,86-88,90,91
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131,137,138,142,143,147,151,155,156
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pectoris occurred in a participant
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statistical test results for the ob
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individual Q1-Q15 items, 104,106,15
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Proportion of participants with hea
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erectile maintenance frequency, IIE
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Oral Treatments — Phosphodiestera
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Patients were instructed to take th
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Results obtained from two trials 19
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improved erections was higher in pa
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Clinically homogenous groups of pat
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Oral Treatments — Phosphodiestera
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The approximate proportion of smoke
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value was not reported). Even thoug
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Tadalafil (20 mg) versus tadalafil
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scheduled dosing regimen (90 percen
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Proportion of patients with improve
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Sublingual Treatments - Apomorphine
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been taking over the past two or fo
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apomorphine (5 and 6 mg: 38 and 49
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heterogeneity with respect to popul
Page 84 and 85: Finally, two studies reported on wh
Page 86 and 87: the second study, prolonged erectio
Page 88 and 89: Moxisylate versus placebo. One tria
Page 90 and 91: Quantitative SynthesisThere was a l
Page 92 and 93: erection” versus one placebo trea
Page 94 and 95: methods of allocation concealment.
Page 96 and 97: Prazosin (IU) versus placebo. One t
Page 98 and 99: reported adequate allocation concea
Page 101 and 102: Hormonal Treatments Literature Sear
Page 103 and 104: Harms. In the first trial, the diff
Page 105 and 106: sex with partner (scale 1-6, with =
Page 107 and 108: daily for 4 weeks followed by concu
Page 109 and 110: (MEDQoL) score (range 0-100) compar
Page 111 and 112: group (16.7, 12.5, and 8.3 percent,
Page 113 and 114: Question 3a. What Are the harms of
Page 115 and 116: Chapter 4. DiscussionThis evidence
Page 117 and 118: Question 1: What is the Clinical Ut
Page 119 and 120: Questions 2-3: What are the Benefit
Page 121 and 122: Harms. There were no obvious differ
Page 123 and 124: alone. Compared with trimix alone,
Page 125 and 126: PhentolamineEfficacy. The results i
Page 127 and 128: Question 2a-b: Do Specific Patient
Page 129 and 130: Methodological and Logistic Limitat
Page 131: Tables and Figures.Summary TablesTa
Page 137: 124Study details 1 Study Design Set
Page 141: 126Study Details 2 Study Design Set
Page 145: Table 3: Prevalence of Hypogonadism
Page 157: 134StudyEDDetails 8 Study Design Se
Page 161: 136Study details 10 Study design Se
Page 164 and 165: Author yearCappelleri (2000)Albuque
Page 166 and 167: Table 12: Intracavernosal Injection
Page 168 and 169: Treatment Control Relative RiskStud
Page 170 and 171: StudyED etiologyTreatmentGroup% (n/
Page 172 and 173: StudyAdverse EventsPgE 1 vs. Papave
Page 174 and 175: StudyAdverse EventsTrimix vs. Trimi
Page 176 and 177: StudyAdverse EventsTreatmentGroup%
Page 178 and 179: StudyRosen 2004AE > 5% inboth treat
Page 180 and 181: Study ED Etiology OutcomeTreatmentG
Page 182 and 183: StudyPeterson 1998Adverse EventTrea
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Table 20: Alprostadil (Topical Crea
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Table 22: Topical Treatment: Patien
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Table 23:Testosterone: Improvement
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Study/patient CharacteristicsCavall
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Table 25: Testosterone Treatment: I
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Study/patientCharacteristicsOutcome
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Study/patientCharacteristicsShabsig
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study withdrawalDihydrotestosterone
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Testosterone 1% Gel + Sildenafil 10
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176Author (year)CountrySpeel (2005)
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178Pomeranz(2002)Pomeranz(2005)Sinh
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StudyStudyDesignPatientsTreatment(s
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Figures Note: Figure 1 (Analytic Fr
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Figure 9. Headache (all cause)Figur
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Figure 13. Improved erection (GEQ-Q
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Figure 1. The mean IIEF-Q3 score: m
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Figure 26. Any adverse event (all c
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Figure 34. Improved erection (GEQ-Q
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Figure 40. Successful intercourse a
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Figure 46. Serious adverse eventsFi
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Figure 52. The mean IIEF “EF doma
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Figure 58. Flushing (all cause)Figu
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Figure 64. Mean per-patient percent
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Figure 70. Improved erection (GAQ-Q
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References and Included Studies 1.
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52. Deeks JJ, Higgins JP, Altman DG
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treatment withdrawal. Int J Impot R
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133. Olsson AM, Persson CA, Swedish
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May-Jun;27(3):480]. J Androl 2006Ma
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209. Hellstrom WJ, Elhilali M, Home
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study in 14 European countries. J S
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prostaglandin E1. J Urol 1992 Oct;1
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327.and mood in men with erectile d
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371. Shmueli J, Israilov S, Segenre
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List of Acronyms/AbbreviationsCLINI
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IU/Lkgkg/m2mmgmg/dmLmmol/LNng/dLng/
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Appendix A. Search StrategiesMedlin
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22. erecti$.tw.23. 21 or 2224. CLIN
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14. 3 and 1315. limit 14 to yr="199
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1. exp Sleep Apnea Syndromes/2. Opt
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Appendix B. Data Assessment, Data A
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Cross-national ecological analysisO
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Randomized Controlled Trials (Jadad
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Appendix C. Evidence TablesC1-Oral
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AuthorFundingN; study design; eligi
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C-11 AuthorFundingN; study design;
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C-83 C2-Oral Vardenafil AuthorFundi
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C-105 C3-Oral Tadalafil AuthorFundi
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C-135 F4-Apomorphine (sublingual) A
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C-191 C6-Subcutaneous Treatment Tri
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C-195 C7- Intra-urethral Suppositor
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C-237 C10-Off Label Treatments Auth
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References(1) Abdel-Naser MB, Imam
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in Colombia, Ecuador, and Venezuela
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(67) Rendell MS, Rajfer J, Wicker P
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(100) Martin-Morales A, Meijide F,
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controlled study. Urology 2006; 68(
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(166) el-Saleh JC, Keogh EJ, Chew K
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(201) Wessells H, Levine N, Hadley
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with hypogonadal symptoms. Arch Gen
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Appendix D. Reference List of Exclu
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Akduman B, Crawford E D. The PCPT:
Page 807 and 808:
Anderson R U, Wise D, Sawyer T et a
Page 809 and 810:
Atala A, Amin M. Current concepts i
Page 811 and 812:
Barbaree H E, Mewhort D J. The effe
Page 813 and 814:
Bereczky Z, Bolus M, Chetty P et al
Page 815 and 816:
Blaya C, Seganfredo A C, Dornelles
Page 817 and 818:
Brioni J D, Moreland R B, Cowart M
Page 819 and 820:
Campbell S F. Science, art and drug
Page 821 and 822:
Champion H C. Erectile dysfunction
Page 823 and 824:
Chung W S, Choi H K. Erotic erectio
Page 825 and 826:
Crasilneck Harold B. Hypnotic techn
Page 827 and 828:
De Leval J, Boca P, Youssef E et al
Page 829 and 830:
Doggrell S A. Combination of finast
Page 831 and 832:
Eardley I. Optimisation of PDE5 Inh
Page 833 and 834:
Evans M F. Critical appraisal: Lose
Page 835 and 836:
Formenti S C, Lieskovsky G, Simonea
Page 837 and 838:
Garcia-Campayo Javier, Sanz-Carrill
Page 839 and 840:
Gleave M, Qian J, Andreou C et al.
Page 841 and 842:
Carson C C. Erectile dysfunction: E
Page 843 and 844:
Glina S. Testosterone and erectile
Page 845 and 846:
Kalsi J S, Bahadur G, Muneer A et a
Page 847 and 848:
McMahon C G. New treatment options
Page 849 and 850:
Padma-Nathan H. Efficacy and tolera
Page 851 and 852:
Shabsigh R, Rajfer J, Aversa A et a
Page 853 and 854:
Wincze John P, Carey Michael P. Sex
Page 855 and 856:
Tan R S. Novel treatment options fo
Page 857 and 858:
Gupta A, Cohen B H, Ruggieri P et a
Page 859 and 860:
Anonymous. Sildenafil appears safe
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Bella A J, Brock G B. Tadalafil: A
Page 863 and 864:
Carson C C, Burnett A L, Levine L A
Page 865 and 866:
Curran M, Keating G. Tadalafil.[err
Page 867 and 868:
Fagan T C, Buttler S, Marbury T et
Page 869 and 870:
Greenstein A, Plymate S R, Katz P G
Page 871 and 872:
Hunter R H, Joy C B, Kennedy E et a
Page 873 and 874:
Kloner R A, Mitchell M, Emmick J T.
Page 875 and 876:
Long R L, Sherman L S, Lombardi T J
Page 877 and 878:
Miller N, Smolkin M E, Bissonette E
Page 879 and 880:
Nurnberg H, George. Erectile Dysfun
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Porst H, Giuliano F, Glina S et al.
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Salonia Andrea, Briganti Alberto, M
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Solursh Lionel P, Solursh Diane S.
Page 887 and 888:
van Basten J P, Van Driel M F, Hoek
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Yasumoto R, Nishisaka N, Sakakura T
Page 891 and 892:
Chen J, Godschalk M F, Katz P G et
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Hellstrom W J. Vardenafil: a new ap
Page 895 and 896:
Webb D J, Muirhead G J, Wulff M et
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Kim J M, Joh Y D, Huh J D et al. Do
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Tariq S H, Haleem U, Omran M L et a
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Aizenberg Dov, Gur Shay, Zemishlany
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Beretta G, Marzotto M, Zanollo A et
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Cheng E. Real-life safety and effic
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English J C, King D H C, Foley J P.
Page 909 and 910:
Goldstein I, Auerbach S, Padma-Nath
Page 911 and 912:
Jackson G. Sildenafil (Viagra): New
Page 913 and 914:
Lane B Z, Ausmundson S J, Butler R
Page 915 and 916:
McMahon C G. An attempt to standard
Page 917 and 918:
Mulhall J P, Land S, Parker M et al
Page 919 and 920:
Pohanka M, Kanovsky P, Bares M et a
Page 921 and 922:
Ruof J, Graf-Morgenstern M, Mnller
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Sparwasser C, Treiber U, Bahren W e
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Wagner G, Montorsi F, Auerbach S et
Page 927 and 928:
Anderson R A, Martin C W, Kung A W
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Baggaley M R, Hirst J F, Watson J P
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Buvat J, Boujadoue G. Testosterone
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Contreras L N, Masini A M, Danna M
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Engelhardt P F, Daha L K, Zils T et
Page 937 and 938:
Glasser S P. Safety of PDE 5 inhibi
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Holtkamp M, Weissinger F, Meierkord
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Kirby R S. Report from London. Pros
Page 943 and 944:
Lexchin J. New drugs with novel the
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Mealy N E. Avanafil. Drugs of the F
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Nakata M, Takashima S, Kaminou T et
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Phillips B G, Kato M, Pesek C A et
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Saad F, Grahl A S, Aversa A et al.
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Sipski M, Alexander C, Guo X et al.
Page 955 and 956:
Traish A M, Goldstein I, Kim N N. T
Page 957 and 958:
Wilt T J, Fink H A. Is antidepressa
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Price D E, Cooksey G, Jehu D et al.
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Bolona E R, Uraga M V, Haddad R M e
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Anonymous. Sublingual apomorphine:
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Bouloux P. Testim 1% testosterone g
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Christ B, Brockmeier D, Hauck E W e
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Fein R L. Classification of sexual
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Green B G, Martin S. Clinical asses
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John H, Lehmann K, Hauri D. Intraur
Page 975 and 976:
Lee W R. The role of androgen depri
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Mealy N E. Alprostadil cream. Drugs
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Murphy J C, Srinivas S, Terris M K.
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Pommerville P. Drug treatments for
Page 983 and 984:
Saie D J, Sills E S. Hyperprolactin
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Steidle C P, McCullough A R, Kamine
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Weiss J N, Badlani G H, Ravalli R e
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Anonymous. Study shows patients tak
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Bartlik Barbara D, Kaplan Peter, Ka
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Cawello W, Schweer H, Dietrich B et
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Del Popolo G, Li Marzi V, Mondaini
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Gallo L, Perdona S, Autorino R et a
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Hofner K, Claes H, De Reijke T M et
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Kloner R A, Hutter A M, Emmick J T
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Maan Z, Arya M, Shergill I et al. P
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Montorsi F, Strambi L F, Guazzoni G
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Phelps J S, Jain A, Monga M. The Ps
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Sato Y, Suzuki N, Adachi H et al. E
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Strachan M W, Teoh W L, Don-Wauchop
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Weinhardt L S, Carey M P. Prevalenc
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Appendix E. Additional Acknowledgme
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Appendix F. Quality AssessmentRando
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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Jadad Q-1AuthorYearJadad Q-2 Jadad
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Quality Assessment of Observational
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Appendix G. Funnel PlotsSildenafilF
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Figure G-3. Sildenafil (any dose) v
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VardenafilAny dose vs. PlaceboFigur
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Figure G-11. Vardenafil (any dose)
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Figure G-13. Tadalafil (20 mg) vs.
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20 mg vs. 10 mgFigure G-15. Tadalaf
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Appendix H. Instruments Used in the
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1 = Very dissatisfied2 = Moderately
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Appendix I. List of Unobtained Arti
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