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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01335464




Registration number
NCT01335464
Ethics application status
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
25/07/2016

Titles & IDs
Public title
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
Scientific title
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2010-024251-87
Secondary ID [2] 0 0
1199.32
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - BIBF 1120

Experimental: BIBF 1120 - patient receives capsules containing BIBF 1120 twice a day

Placebo comparator: placebo - patient receives capsules identical to those containing active drug


Treatment: Drugs: placebo
placebo matching BIBF1120, BID

Treatment: Drugs: BIBF 1120
BIBF1120 BID (twice daily)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
Timepoint [1] 0 0
baseline and 52 weeks
Secondary outcome [2] 0 0
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [3] 0 0
Baseline and 52 weeks
Secondary outcome [4] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [4] 0 0
Baseline and 52 weeks
Secondary outcome [5] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [5] 0 0
Baseline and 52 weeks
Secondary outcome [6] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [6] 0 0
Baseline and 52 weeks
Secondary outcome [7] 0 0
Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold
Timepoint [7] 0 0
Baseline and 52 weeks
Secondary outcome [8] 0 0
Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold
Timepoint [8] 0 0
Baseline and 52 weeks
Secondary outcome [9] 0 0
FVC Responders Using 10% Threshold at 52 Weeks
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
Proportion of FVC Responders Using 5% Threshold at 52 Weeks
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [11] 0 0
Baseline and 52 weeks
Secondary outcome [12] 0 0
Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [12] 0 0
Baseline and 52 weeks
Secondary outcome [13] 0 0
Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [13] 0 0
Baseline and 52 weeks
Secondary outcome [14] 0 0
Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [14] 0 0
baseline and 52 weeks
Secondary outcome [15] 0 0
Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [15] 0 0
Baseline and 52 weeks
Secondary outcome [16] 0 0
Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [16] 0 0
baseline and 52 weeks
Secondary outcome [17] 0 0
Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [17] 0 0
Baseline and 52 weeks
Secondary outcome [18] 0 0
Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)
Timepoint [18] 0 0
Baseline and 52 weeks
Secondary outcome [19] 0 0
Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [19] 0 0
52 weeks
Secondary outcome [20] 0 0
Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)
Timepoint [20] 0 0
baseline, 12 weeks, 24 weeks and 52 weeks
Secondary outcome [21] 0 0
Risk of an Acute IPF Exacerbation Over 52 Weeks
Timepoint [21] 0 0
52 weeks
Secondary outcome [22] 0 0
Time to Death Over 52 Weeks
Timepoint [22] 0 0
52 weeks
Secondary outcome [23] 0 0
Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)
Timepoint [23] 0 0
52 weeks
Secondary outcome [24] 0 0
Time to On-treatment Death
Timepoint [24] 0 0
52 weeks
Secondary outcome [25] 0 0
Time to Death or Lung Transplant Over 52 Weeks
Timepoint [25] 0 0
52 weeks
Secondary outcome [26] 0 0
Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.
Timepoint [26] 0 0
52 weeks
Secondary outcome [27] 0 0
Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks
Timepoint [27] 0 0
Baseline and 52 weeks
Secondary outcome [28] 0 0
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks
Timepoint [28] 0 0
Baseline and 52 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC>= 50% predicted of normal
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
515
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
1199.32.61001 Boehringer Ingelheim Investigational Site - Camperdown
Recruitment hospital [2] 0 0
1199.32.61002 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [3] 0 0
1199.32.61003 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [4] 0 0
1199.32.61005 Boehringer Ingelheim Investigational Site - Frankston
Recruitment hospital [5] 0 0
1199.32.61004 Boehringer Ingelheim Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Jette
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Yvoir
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Changsha
Country [26] 0 0
China
State/province [26] 0 0
Chengdu
Country [27] 0 0
China
State/province [27] 0 0
Nanchang
Country [28] 0 0
China
State/province [28] 0 0
Xi'An
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Prague 4
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Prague 8
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Usti nad Labem
Country [32] 0 0
France
State/province [32] 0 0
Bobigny
Country [33] 0 0
France
State/province [33] 0 0
Nice Cedex 1
Country [34] 0 0
France
State/province [34] 0 0
Paris Cedex 15
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 18
Country [36] 0 0
France
State/province [36] 0 0
Paris cedex 20
Country [37] 0 0
France
State/province [37] 0 0
Reims cedex
Country [38] 0 0
France
State/province [38] 0 0
Rennes Cedex 9
Country [39] 0 0
Germany
State/province [39] 0 0
Bamberg
Country [40] 0 0
Germany
State/province [40] 0 0
Donaustauf
Country [41] 0 0
Germany
State/province [41] 0 0
Essen
Country [42] 0 0
Germany
State/province [42] 0 0
Freiburg/Breisgau
Country [43] 0 0
Germany
State/province [43] 0 0
Gießen
Country [44] 0 0
Germany
State/province [44] 0 0
Großhansdorf
Country [45] 0 0
Germany
State/province [45] 0 0
Heidelberg
Country [46] 0 0
Germany
State/province [46] 0 0
Mainz
Country [47] 0 0
India
State/province [47] 0 0
Ahmedabad
Country [48] 0 0
India
State/province [48] 0 0
Coimbatore
Country [49] 0 0
India
State/province [49] 0 0
Jaipur
Country [50] 0 0
India
State/province [50] 0 0
Kolkatta
Country [51] 0 0
India
State/province [51] 0 0
Mumbai
Country [52] 0 0
Ireland
State/province [52] 0 0
Dublin
Country [53] 0 0
Israel
State/province [53] 0 0
Haifa
Country [54] 0 0
Israel
State/province [54] 0 0
Petah Tiqwa
Country [55] 0 0
Israel
State/province [55] 0 0
Rehovot
Country [56] 0 0
Italy
State/province [56] 0 0
Catania
Country [57] 0 0
Italy
State/province [57] 0 0
Chieti Scalo
Country [58] 0 0
Italy
State/province [58] 0 0
Forli'
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Modena
Country [61] 0 0
Italy
State/province [61] 0 0
Monza
Country [62] 0 0
Italy
State/province [62] 0 0
Napoli
Country [63] 0 0
Italy
State/province [63] 0 0
Padova
Country [64] 0 0
Italy
State/province [64] 0 0
Pisa
Country [65] 0 0
Italy
State/province [65] 0 0
Roma
Country [66] 0 0
Italy
State/province [66] 0 0
Siena
Country [67] 0 0
Japan
State/province [67] 0 0
Bunkyo-ku,Tokyo
Country [68] 0 0
Japan
State/province [68] 0 0
Kiyose, Tokyo
Country [69] 0 0
Japan
State/province [69] 0 0
Kumagaya, Saitama
Country [70] 0 0
Japan
State/province [70] 0 0
Minato-ku, Tokyo
Country [71] 0 0
Japan
State/province [71] 0 0
Naka-gun, Ibaraki
Country [72] 0 0
Japan
State/province [72] 0 0
Ota-ku, Tokyo
Country [73] 0 0
Japan
State/province [73] 0 0
Sendai, Miyagi
Country [74] 0 0
Japan
State/province [74] 0 0
Shibuya-ku, Tokyo
Country [75] 0 0
Japan
State/province [75] 0 0
Shimotsuke,Tochigi
Country [76] 0 0
Japan
State/province [76] 0 0
Shinjuku-ku, Tokyo
Country [77] 0 0
Japan
State/province [77] 0 0
Yokohama, Kanagawa
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Aberdeen
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Birmingham
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Leeds
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Liverpool
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Oxford
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Westbury on Trym

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
Trial website
https://clinicaltrials.gov/study/NCT01335464
Trial related presentations / publications
Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.
Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.
Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.
Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.
Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.
Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.
Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.
Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.
Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.
Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.
Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.
Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.
Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum In: N Engl J Med. 2015 Aug 20;373(8):782. doi: 10.1056/NEJMx150012.
Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01335464