Abnormal haemoglobin causes? Option 1.only thlassemia.2only sickle cell anaemia.3A&B both.4 haemophilia
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option 4 must be the correct answer
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Protocol
This trial protocol has been provided by the authors to give readers additional information about their work.
Protocol for: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.
N Engl J Med. DOI: 10.1056/NEJMoa1402454Protocol and Statistical Analysis Plan
This supplement contains the following items for the ION-1 trial (NCT01701401):
The final protocol................................................................................................................................................. 2
Statistical analysis plan......................................................................................................................................... 128
Supplement to: Afdhal N, Zeuzem S, Kwo P, et al. Sofosbuvir and Ledipasvir for 12 or 24 Weeks in
Previously Untreated HCV Genotype 1. N Engl J Med 2014
1CLINICAL STUDY PROTOCOL
Study Title: A Phase 3, Multicenter, Randomized, Open-Label Study to
Investigate the Efficacy and Safety of Sofosbuvir/GS-5885
Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in
Treatment-Naïve Subjects with Chronic Genotype 1 HCV
Infection
Sponsor: Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404, USA
IND No.:
EudraCT Number:
115,268
2012-003387-43
Indication: Hepatitis C Virus Infection
Protocol ID: GS-US-337-0102
Gilead Sciences Study
Director:
Name: Jenny Yang, PharmD
Telephone: (650) 372-7989
Fax: (650) 524-9466
E-mail: [email protected]
Protocol Version/Date: Original: 29 August 2012
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or
under control of Gilead Sciences, Inc., and is provided to you in confidence as an
investigator, potential investigator, or consultant, for review by you, your staff, and an
applicable Institutional Review Board or Independent Ethics Committee. The information is
only to be used by you in connection with authorized clinical studies of the investigational
drug described in the protocol. You will not disclose any of the information to others without
written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain
informed consent from those persons to whom the drug may be administered.
2
This trial protocol has been provided by the authors to give readers additional information about their work.
Protocol for: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.
N Engl J Med. DOI: 10.1056/NEJMoa1402454Protocol and Statistical Analysis Plan
This supplement contains the following items for the ION-1 trial (NCT01701401):
The final protocol................................................................................................................................................. 2
Statistical analysis plan......................................................................................................................................... 128
Supplement to: Afdhal N, Zeuzem S, Kwo P, et al. Sofosbuvir and Ledipasvir for 12 or 24 Weeks in
Previously Untreated HCV Genotype 1. N Engl J Med 2014
1CLINICAL STUDY PROTOCOL
Study Title: A Phase 3, Multicenter, Randomized, Open-Label Study to
Investigate the Efficacy and Safety of Sofosbuvir/GS-5885
Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in
Treatment-Naïve Subjects with Chronic Genotype 1 HCV
Infection
Sponsor: Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404, USA
IND No.:
EudraCT Number:
115,268
2012-003387-43
Indication: Hepatitis C Virus Infection
Protocol ID: GS-US-337-0102
Gilead Sciences Study
Director:
Name: Jenny Yang, PharmD
Telephone: (650) 372-7989
Fax: (650) 524-9466
E-mail: [email protected]
Protocol Version/Date: Original: 29 August 2012
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or
under control of Gilead Sciences, Inc., and is provided to you in confidence as an
investigator, potential investigator, or consultant, for review by you, your staff, and an
applicable Institutional Review Board or Independent Ethics Committee. The information is
only to be used by you in connection with authorized clinical studies of the investigational
drug described in the protocol. You will not disclose any of the information to others without
written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain
informed consent from those persons to whom the drug may be administered.
2
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