PROspective Multiethnic Validation of the BEhçet's Syndrome Overall Damage Index (BODI): the PROBE Study
Conditions: Behçet's Syndrome (BS)
Sponsor: University of Cagliari

 
 
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PROspective multiethnic validation of the  
BEhçet’s syndrome Overall Damage Index (BODI):  
the PROBE study 
 
 
 
 
 
 
 
 
 
 

 
 
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INDEX 
 
 
ADMINISTRATIVE INFORMATION 
 
 
 
 
 
 
 
PAG. 3 
ROLES AND RESPONSIBILITIES 
 
 
 
 
 
 
 
PAG.4 
BACKGROUND 
 
 
 
 
 
 
 
 
 
PAG.6 
OBJECTIVES  
 
 
 
 
 
 
 
 
 
PAG. 6 
METHODS 
 
 
 
 
 
 
 
 
 
 
PAG.7 
STUDY TIMELINE 
 
 
 
 
 
 
 
 
 
PAG. 13 
PUBLICATION RULES  
 
 
 
 
 
 
 
 
PAG. 14 
ETHIC AND REGULATORY ISSUES 
 
 
 
 
 
 
 
PAG. 14 
REFERENCES  
 
 
 
 
 
 
 
 
 
PAG. 17 
 
 
 

 
 
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ADMINISTRATIVE INFORMATION 
TITLE: 
PROspective multiethnic validation of the BEhçet’s syndrome Overall Damage Index (BODI): the 
PROBE study 
 
Data Category 
Information 
Primary registry and study 
identifying number 
In progress 
Date of registration in primary 
registry 
In progress 
Source(s) of monetary or material 
support 
No funding 
Primary sponsor 
NA 
Secondary sponsor(s) 
NA 
Contact for public queries 
matteopiga@unica.it  
Contact for scientific queries 
bodiproject@gmail.com  
Public title 
PROBE study 
Scientific title 
PROspective multiethnic validation of the BEhçet’s 
syndrome Overall Damage Index (BODI): the PROBE study 
Countries of recruitment 
Worldwide 
Health condition studied 
Behçet’ syndrome 
Study design 
Observational study 
 
PROTOCOL VERSION: 1.0 
 
Issue Date: 
25 March 2021 
Protocol amendment number: 
1 
Author(s): 
Matteo Piga, Alberto Floris, Gülen Hatemi 
 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document is the property of the University of Pisa and therefore is provided 
to you in confidence for review by you, your staff, an applicable Ethics Committee/Institutional Review, and 
regulatory authorities. It is understood that the information will not be disclosed to others without prior 
written approval except to the extent necessary to obtain informed consent from those persons to whom 
the medication may be administered. 
 
 

 
 
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LIST OF THE INVOLVED RESEARCH CENTRES AND ROLES AND RESPONSIBILITIES OF INVESTIGATORS 
Research Centres 
Investigators’ name and role 
1. Rheumatology Unit, University and AOU of Cagliari, 
Monserrato – Italy (Proposing and coordinating Centre) 
Matteo Piga (Italy) 
Principal Investigator 
Alberto Cauli (Italy) 
Executive committee 
Alberto Floris (Italy) 
Executive committee 
2. Department of rheumatology | National Reference 
Centre for Rare Auto-Immunes Diseases, Hôpital de 
Hautepierre, Strasbourg Cedex, France 
Laurent Arnaud (France) 
Executive committee 
3. Université des Sciences et de la Technologie Houari 
Boumediene: Algiers 
Houda Belguendouz (Algeria) 
Investigator 
4. Department of Rheumatology, Clinical Immunology and 
Allergy, University of Crete School of Medicine - Greece 
George Bertsias (Greece) 
Investigator 
5. Department of Rheumatology, Mayo Clinic, Jacksonville, 
Florida - USA 
Ronald Butendieck (USA) 
Investigator 
6. Rheumatology Unit, University of Siena. Policlinico Le 
Scotte, Siena - Italy 
Luca Cantarini (Italy) 
Investigator 
7. Department of Autoimmune Diseases, Hospital Clinic, 
IDIBAPS, University of Barcelona - Spain 
Ricard Cervera (Spain) 
Investigator 
Gerard Espinosa (Spain) 
Investigator 
8. Clinical Immunology Unit, Centro Hospitalar do Porto and 
UMIB, ICBAS, Universidade do Porto, Portugal. 
Joao Correja (Portugal) 
Investigator 
Carlos Vasconcelos (Portugal) 
Investigator 
9. Ophthalmology Unit, Department of Medical Sciences, 
Surgery and Neurosciences, University of Siena , Italy 
Claudia Maria Fabiani (Italy) 
Investigator 
10. Department 
of 
Medical 
Sciences, 
Section 
of 
Rheumatology, AOU S. Anna, University of Ferrara - Italy 
Marcello Govoni (Italy) 
Investigator 
11. Department 
of 
Internal 
Medicine, 
Division 
of 
Rheumatology, Istanbul University - Cerrahpasa  
Gülen Hatemi (Turkey) 
Investigator 

 
 
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Research Centres 
Investigators’ name and role 
12. University of Tunis El Manar, Faculty of Medicine of 
Tunis, LR99ES11 Tunis, Tunisia; Rabta Hospital, Service of 
Internal Medicine, Jebbari 1007, Tunis, Tunisia. 
Habib Mohamed Houman 
(Tunisia) 
Investigator 
13. Connective Tissue Diseases Research Center, Tabriz 
University of Medical Sciences, Tabriz, Iran. 
Alireza Khabbazi (Iran) 
Investigator 
14. Department of Dermatology, Severance Hospital, 
Cutaneous Biology Research Institute, Yonsei University 
College of Medicine, Seoul, Korea 
Do Young Kim (South Korea) 
Investigator 
15. Department of Emergency and Organ Transplantation, 
Rheumatology Unit, University of Bari - Italy 
Florenzo Iannone (Italy) 
Investigator 
16. Department of Medicine, Nazarbayev University School 
of Medicine (NUSOM), Nur-Sultan, Kazakhstan. 
Dimitri Poddighe (Kazakhstan) 
Investigator 
17. Internal Medicine Department, Rheumatology and 
Clinical Immunology Unit, Faculty of Medicine, Cairo 
University, Cairo, Egypt. 
Gaafar Ragab (Egypt) 
Investigator 
18. Sorbonne Universités AP-HP, Groupe Hospitalier Pitié-
Salpêtrière, Département de Médecine Interne et 
Immunologie Clinique, Paris, France. 
David Saadoun  (France) 
Investigator 
19. Division of Rheumatology, Universidade Federal de São 
Paulo, São Paulo, Brazil. 
Alexandre WS de Souza (Brazil) 
Investigator 
20. Department of Immunology, School of Medicine, Tehran 
University of Medical Sciences, Tehran, Iran. 
Farhad Shahram (Iran) 
Investigator 
21. Department of Rheumatology, Peking Union Medical 
College Hospital, Beijing, China 
Wenjie Zheng (China) 
Investigator 
22. Internal Medicine Department, Ibn Sina University 
Hospital, Rabat, Morocco. 
Tazi Mezalek Zoubida (Moroc) 
Investigator 
 
 
 

 
 
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BACKGROUND 
Behçet’s syndrome (BS) is a multisystem inflammatory disease of unknown etiology, 
characterized by strong genetic background, distinctive geographic distribution, and wide variability 
in clinical presentation [1]. Disease activity related to BS as well as chronic exposure to medications 
may lead to the development and accrual of irreversible organ damage resulting in impairment of 
quality of life, disability, and increased mortality [2]. For these reasons, organ damage was included 
in the OMERACT outcome core set for BS [3]. 
The Behçet’s syndrome Overall Damage Index (BODI) is a recently developed tool to identify and 
measure organ damage in BS [2]. The BODI is grounded in a solid evidence-based and consensus-
based methodology, and its preliminary validation on a multicenter cohort of Southern European 
patients showed highly promising performance in terms of comprehensiveness, specificity, 
reliability, sensitivity to change, and feasibility [2]. 
Nevertheless, a prospective validation with a wider and ethnically heterogeneous cohort of BS 
patients is needed to generally evaluate the impact of those BODI items seldom recorded or absent 
in the preliminary validation cohort and to weigh the damage items depending on their relevance 
for predicting major outcomes. 
 
OBJECTIVES 
General objectives 
The general objectives of the PROBE study are to further test the comprehensiveness of the BODI 
(content validity) in a wide and ethnically heterogeneous cohort of BS patients, and investigate how 
damage assessed by the BODI correlates with other major long-term disease outcomes (criterion 
validity), with the ultimate goal of drafting a weighing system for each BODI item. 
Specific Objectives 
1. To test the comprehensiveness of the instrument in a wide and ethnically heterogeneous 
cohort of BS patients, evaluating the prevalence of those BODI items seldom recorded or absent 
in the preliminary validation cohort 
2. To describe possible differences in the entity and type of damage accrual in BS patients from 
different geographical areas. 
3. To identify the factors independently associated with damage development and accrual. 

 
 
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4. To investigate the association between the results of the baseline BODI measurement (BODI 
≥1, BODI score, and BODI ranking) and the 5-years mortality rate. 
5. To investigate the association between the results of the baseline BODI measurement (BODI 
≥1, BODI score, and BODI ranking)and the 5-years hospitalization rate. 
6. To weigh each item of damage depending on their relevance in predicting mortality. 
 
METHODS 
 
Study design 
PROBE is an observational multicenter cohort study, consisting of a cross-sectional and a 5-years 
prospective phase, designed to target the major study objectives, such as testing the content and 
criterion validity of the BODI and drafting a weighing system for each BODI items. 
During the study, patients will undergo a routine clinical assessment, as scheduled in their follow-
up program. No further clinical, laboratory or instrumental investigations are required in addition 
to those provided according to good clinical practice. Treatment prescription will be evaluated by 
each investigator independently from the study and according to the international and local 
guidelines and the good clinical practice. 
 
Patients 
The study population will consist of consecutive BS patients diagnosed according to the ICBD or 
ISG classification criteria [4,5] recruited in Centers with expertise for BS. 
Inclusion criteria: 
• Diagnosis of BS according to ICBD or ISG criteria; 
Exclusion criteria: 
• subjects unable or unwilling to make themselves available for the duration of the study 
and/or are unwilling to follow interval visits. 
Any effort should be addressed by investigators to minimize the rate of lost to follow-up and 
guarantee the completeness of the database.  
 
 
 

 
 
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Data collection 
Data will be collected at the time of recruitment (baseline, T0) and then annually (± 1 month) for 
5 years. Overall, 6 visits are planned to be recorded (T0, T1, T2, T3, T4, T5). Details on the data 
required at each visit are reported in table 1.  
A query management system (QMS) will manually track data queries so they can be adequately 
individualized and resolved. QMS substantially minimizes and even eliminates the risk of invalid data 
being unnoticed. Collected data will be checked annually and data queries (e.g., data issue) will be 
forwarded to Investigators. Data queries will only be resolved in the following ways: 
- 
by correcting the error, in other words entering a new value that is valid; 
- 
by marking the data in conflict as correct. 
 
  
Table 1. Data collection at each scheduled visit 
 
T0 
T1 
T2 
T3 
T4 
T5 
Months 
Baseline 
12 (±1) 24 (±1) 36 (±1) 48 (±1) 60 (±1) 
Demographics 
P 
 
 
 
 
 
Comorbidities 
P 
 
 
 
 
 
Cumulative disease manifestations  
P 
 
 
 
 
 
Active manifestations between visits 
 
P 
P 
P 
P 
P 
BD current activity form (BDCAF) 
P 
P 
P 
P 
P 
P 
BODI score 
P 
P 
P 
P 
P 
P 
Physician global assessment (PGA) 
P 
P 
P 
P 
P 
P 
Patient’s global assessment (PtGA) 
P 
P 
P 
P 
P 
P 
Patient’s damage assessment (PtDA) 
P 
P 
P 
P 
P 
P 
Ongoing treatment 
P 
P 
P 
P 
P 
P 
N of relapses (between visits) 
Last 5 yrs 
P 
P 
P 
P 
P 
N of hospitalizations (between visits) 
Last 5 yrs 
P 
P 
P 
P 
P 
Death 
 
P 
P 
P 
P 
P 
 
 
 
 

 
 
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Variables  
Details on the variables that are requested to be recorded are reported below: 
• Demographics: 
o Gender (male/female) 
o Date of birth 
o Date of onset:  
a) first disease manifestation including oral aphtosis;  
b) first disease manifestation excluding oral aphtosis  
o Date of diagnosis 
o Date of enrolment 
o Smoking: 
▪ never smoker,  
▪ current smoker,  
▪ past smoker 
o Country of origin 
o Country of residence 
o  Ethnicity:  
▪ Caucasian; 
▪ Asian;  
▪ Hispanic;  
▪ Afro-American;  
▪ Arab; 
▪ Other (please specify) 
o Education level: 
▪ Illiterate 
▪ Primary school 
▪ Secondary School 
▪ College/University 
o Comorbidities:  
▪ Fibromyalgia 
▪ Blood hypertension 

 
 
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▪ Dyslipidemia 
▪ Obesity (BMI>30) 
▪ Chronic Kidney disease 
▪ Diabetes (diagnosed before onset of BS) 
▪ Other (please specify) 
o Cumulative clinical manifestations: any disease manifestation occurred from the disease 
onset to the enrolment visit (even no longer present at the enrolment visit). The following 
disease manifestations have to be recorded: 
o Oral aphtosis (yes/no) 
o Genital aphtosis (yes/no) 
o Skin lesions (yes/no, if yes specify which type) 
o Ocular (yes/no, if yes specify which type) 
o Vascular (yes/no, if yes specify which type) 
o Neurologic (yes/no, if yes specify which type) 
o Musculoskeletal (yes/no, if yes specify which type) 
o Gastrointestinal yes/no, (if yes specify which type) 
o Pathergy test (yes/no) 
o Others yes/no, (if yes specify which type) 
 
o Active clinical manifestations between visits: manifestations that are present at the time of 
the visit or have occurred since last visit. The following disease manifestations have to be 
recorded: 
o Oral aphtosis (yes/no) 
o Genital aphtosis (yes/no) 
o Skin lesions (yes/no, if yes specify which type) 
o Ocular (yes/no, if yes specify which type) 
o Vascular (yes/no, if yes specify which type) 
o Neurologic (yes/no, if yes specify which type) 
o Musculoskeletal (yes/no, if yes specify which type) 
o Gastrointestinal yes/no, (if yes specify which type) 
o Pathergy test (yes/no) 
o Others yes/no, (if yes specify which type) 

 
 
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• Behçet’s disease current activity form (BDCAF) score: BDCAF is a disease activity assessment 
tool for BS. It depends on an accurate evaluation of clinical features present during the 
month before the date of assessment. The presence/absence of 9 somatic symptoms from 
a list may be recorded, together with eye involvement, nervous system involvement, major 
vessel involvement, as well as the clinician's overall perception of disease activity. The 
transformed index score on an interval scale will be used for analysis in the present study. 
[6] 
• Behçet’s syndrome overall damage index (BODI). It is a tool recently developed to identify 
and measure organ damage in BS. BODI consists of 4 overarching principles and 34 items 
with 12 subitems, categorized into 9 organ/system domains: mucocutaneous, 
musculoskeletal, ocular, vascular, cardiovascular, neuropsychiatric, gastrointestinal, 
reproductive system, and miscellaneous. Each item and subitem scores 1 point. The total 
score ranges from 0 to 46 [2]. In order to score the BODI, each investigator will be provided 
with a user manual and a video tutorial (https://vimeo.com/264992929). 
• Physician’s global assessment of disease activity (PGA). It will be assessed through a single 
question (“How active is the patient’s BS?”) on an anchored 10-cm visual analogic scale (0.5-
cm graded), where 0 corresponded to “no disease activity” and 10 to “the highest disease 
activity.” [7] 
• Patient’s global assessment of disease activity (PtGA). It will be assessed through a single 
question (“How active was your BS during the last week?”) on an anchored 10-cm visual 
analogic (0.5-cm graded), where 0 corresponded to “no disease activity” and 10 to “the 
highest disease activity.” [7] 
• Patient’s damage assessment (PtDA). It will be assessed through a single question (“How 
much irreversible (non-healing) damage have you developed since the diagnosis of BS?”) on 
an anchored 10-cm visual analogic (0.5-cm graded), where 0 corresponded to “no damage” 
and 10 to “the highest amount of damage”. 
• Ongoing treatment: medications that are ongoing at the time of each visit will be classified 
as: 
o Colchicine (yes/no) 

 
 
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o Glucocorticoids (yes/no, if yes specify the current dosage in mg/day of prednisone 
ore equivalents) 
o Conventional immunosuppressant (yes/no, if yes which agent; i.e., azathioprine, 
cyclosporine, cyclophosphamide, thalidomide, methotrexate, sulphasalazine; 
others) 
o Apremilast (yes/no) 
o Biologic immunosuppressant (yes/no, if yes which agent; i.e. anti-TNFalpha agents) 
o Other (yes/no, if yes specify) 
• Number of relapses. Relapse is defined as the onset of a new BS manifestation or 
recurrence/worsening of a pre-existing clinical manifestation resulting in significant 
treatment modifications. Significant treatment modifications will be defined as the starting 
or increasing dosage of corticosteroids, colchicine, apremilast, conventional or biologic 
immunosuppressant. For each relapse, the clinical manifestation inducing the treatment 
modification will be recorded. 
• Number of hospitalizations. Hospitalization will be defined as any admission to the hospital 
(duration at least one day including emergency room) for any reason both related to BS (i.e. 
treatment, management of complications, diagnosis of new manifestations, etc.) and 
unrelated to BS (i.e. surgery, cardiovascular disease, malignancy, etc.). Primary reasons and 
numbers of days of hospitalization will be recorded. 
• Death (yes/no, date of death, cause of death). In this regard, it is of extreme importance to 
make every possible effort to ensure that patients resulting lost to follow-up have not 
deceased. 
 
Statistical analysis 
Descriptive statistics will be performed to report on the prevalence and amount of damage, as 
assessed by the BODI. In the whole study cohort and different geographical sub-groups, the damage 
will be described as: 
- 
prevalence of any damage (BODI ≥1); 
- 
prevalence of any damage in the different BODI domains; 
- 
mean (SD) or median (IQR) BODI score; 

 
 
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- 
ranking of the BODI score will be developed, using a multistate model, depending on the 
distribution of damage in the whole population. 
Univariate and multivariate regression models will be implemented to investigate the significant 
difference between ethnic/geographic groups in terms of prevalence and amount of damage 
accrual. Similarly, univariate and multivariate regression models will be implemented to investigate 
independent factors associated with the development or accrual of damage, as assessed by the 
BODI.  
Multivariate Cox proportional hazards regression models will be created to assess the effect of 
damage (BODI score, BODI ≥1, BODI ranking) on subsequent risk of death with adjustment for 
covariates, including gender, age, disease duration at enrollment, history of major organ 
involvement, disease activity at enrolment, comorbidities (onset before BS diagnosis). Results will 
be presented as hazard ratios with their corresponding 95% confidence intervals. Statistical 
significance will be defined as a P-value <0.05. Finally, adjusted survival estimates obtained from 
these Cox regression models were plotted as survival curves. 
 
Sample size 
According to the results of previous studies, 95% overall 5-year survival is expected [8]. Assuming 
99% and 95% of survival rate in BS patients with and without BODI damage, respectively, and 
assuming 50% prevalence of damage (BODI ≥1) in the study cohort, we estimated a required sample 
size of at least 801 BS patients (alpha type I error = 0.05; beta type II error 0.20) to identify damage 
as a predictor of mortality. Under the assumption of 25%maximum attrition (5% every year), the 
sample size will be increased to 1040 patients. 
 
STUDY TIMELINE 
March 2021 – June 2021:  Investigators involvement and Ethic Approval (if locally required) 
April 2021 – December 2021: Enrollment window 
January 2022 – December 2026: Prospective follow-up window 
 
Publication plan: 
- 
End of 2022 : Publication of Cross-sectional results (content validity) 
- 
End of 2025: Publication of mid-term results (factors associated to damage accrual)  

 
 
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- 
End of 2028: publication of prospective results (construct validity) 
 
PUBLICATION RULES 
Baseline data will be published in a peer-reviewed scientific journal within 1 year from the end 
of recruitment. The full results of the prospective validation will be published in a peer-reviewed 
scientific journal following the completion of the 5-year study. Partial or preliminary results can be 
published beforehand.  
The main publication is the responsibility of the Principal Investigator. Authorship in the main 
publications, as well as in ancillary papers, will be offered to all Investigators who achieve the 
minimum target of 30 patients with complete clinical data after 5 years of follow-up. All the other 
Investigators not reaching these criteria will be included in the collaborator’s list according to the 
table below. Any exception could be evaluated, depending on the number of enrolled patients with 
complete data, by taking into account the national epidemiological distribution of BS. Investigators 
will be listed in authorship according to the number (from highest to lowest) of enrolled patients. 
 
Number of patients 
Investigator 
Local co-investigator 
>100 
Author 
Author 
30-100 
Author 
Collaborator 
<30 
Collaborator 
Collaborator 
 
A list of ancillary publications will be discussed; the study proponent will be granted to access 
the entire data-set and will lead the ancillary publication. Authorship of ancillary papers will be the 
same as the main publications.  
 
ETHIC AND REGULATORY ISSUES 
 
Ethical Committee Approval 
Ethical Committee Approval will be obtained by the Proposing and Coordinating Centre 
(Rheumatology Unit, AOU of Cagliari, Italy) and in the other Research Centres in accordance with 
the policy of the Institutions and local legislation for this kind of study. 
Any future change to the protocol or informed consent needed over the study must be approved 
by Ethical Committee. 
 

 
 
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Data Collection 
Demographic, clinical and therapeutic data will be collected during the enrolment visit and 
annually for 5 years during the routinary follow-up visits for each patient, by reviewing medical 
records and clinical files. No further clinical, laboratory or instrumental investigations will be 
performed in addition to those provide by the good clinical practice. No experimental drugs will be 
administrated. Any possible drug administration will be evaluated independently to the study and 
according to the good clinical practice and the observational nature of the study. 
 
Data entry and security 
The collected data from each Research Centre will be anonymously recorded in an electronic 
spreadsheet. Anonymous data form each Research Centre will be subsequently entered into a single 
password-protected database managed and guarded by the Coordinating Research Centre 
(Rheumatology Unit, AOU of Cagliari, Italy).  To guarantee anonymity, an alphanumeric code will be 
attributed to each patient by the recruiting physician. The correspondence between the 
alphanumeric code and the patient’s identity will be reported in a sperate document, accessible 
only to the recruiting physician. Access to patient final database will be restricted to the Chief 
Investigator and Collaborators above. 
 
Informed consent 
The recruiting physician must inform patients on every aspect of the study, including his right to 
withdraw at any time. The decision of participating to the study must be voluntary.  
In accordance with the policy of the Institutions and local legislation of each Research Centre for 
this kind of study, a signed informed consent will be obtained at the enrolment and a copy of will 
be provided to the recruited patient also. The informed consent will be signed by the recruiting 
physician also. 
 
Study withdrawal 
Every recruited patient can withdrawal from the study at any time for any reason. If his data yet 
entered in the database and not published, they will be removed. 
 
 

 
 
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Data publication and privacy 
Following completion of the study, the full results will be published in a peer-reviewed scientific 
journal. The data anonymity will be guaranteed in accordance with the personal data protect laws. 
 
Insurance cover 
For the purely observational nature of the study, no further insurance coverage should be 
requested in addition to that provided for the standard clinical practice by each Research Centre. 
 
Funding 
No specific funding is provided for the study 
 
 
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2018;14:107–19.  
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validation of the Behçet’s syndrome Overall Damage Index (BODI). RMD Open. BMJ Specialist 
Journals; 2020;6:e001192.  
3. Hatemi G, Meara A, Ozguler Y, Direskeneli H, Mahr A, Shea B, et al. The OMERACT Core Set of 
Domains for Outcome Measures in Behçet Syndrome. Arthritis Care Res. 2020;  
4. Davatchi F, Assaad‐Khalil S, Calamia KT, Crook JE, Sadeghi‐Abdollahi B, Schirmer M, et al. The 
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Lond Engl. 1990;335:1078–80.  
6. Bhakta BB, Brennan P, James TE, Chamberlain MA, Noble BA, Silman AJ. Behçet’s disease: 
evaluation of a new instrument to measure clinical activity. Rheumatology. 1999;38:728–33.  
7. Floris A, Espinosa G, Serpa Pinto L, Kougkas N, Lo Monaco A, Lopalco G, et al. Discordance 
between patient and physician global assessment of disease activity in Behçet’s syndrome: a 
multicenter study cohort. Arthritis Res Ther. 2020;22:278.  
8. Saadoun D, Wechsler B, Desseaux K, et al. Mortality in Behçet’s disease. Arthritis Rheum 
2010;62:2806–12.