Phone: (0863) 2222866 (Extn.: 272), Fax: (0863) 2332866

LALITHA SUPER SPECIALITIES HOSPITALETHICS COMMITTEE

Kothapet, GUNTUR - 522 001. A.P.

Date: 19-Jan-2012

To,

Dr. Polavarapu Veera Raghava SarmaLalltha Super Specialities Hospital (P) Ltd.Heart, Brain & Multi Specialities,Kothapet, Guntur -522001, Andhra Pradesh, India

Ref: A Clinical Outcomes Study to compare the effect of FluticasoneFuroatejVilanterol Inhalation Powder 100j2s-mcg with placebo on Survival inSubjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and ahistory of or at increased risk for cardiovascular disease

Subject: Ethics committee approval -Ofstudy-related documents and conductof the above mentioned study at Lalitha Super Specialities Hospital

Dear Dr. Polavarapu Veera Raghava Sarma,

Your letter dated 12jSepj2011, We have received from you 09 Copies of each of thefollowing study-related documents.

• HZC113782 Protocol dated: 18-Feb-2011, Protocol Amendment Number: 02,

• Sponsor Letter dated 24-February-2011 regarding Protocol Amendment - 2.

• Fluticasone Furoate + Vilanterol Investigator's Brochure, Version: 03, Versiondate: 02 June 2010.

• Vilanterol (GW642444) Investigator's Brochure.eversion: 09, Version date: 06July 2010

• Fluticasone Furoate (GW68s698) Investigator's Brochure, Version: OS,Version date: 14 June 2010

• Sponsor letter dated 19-Aug-2011 regarding annual review- or InvestigatorBrochure for FF, VI and for FFjVI. .

• _HZC113782_India_Dr. Polavarapu Veera Raghava Sarma _English ICF_Version 3.0_07 Apr 2011, Based on HZCl13782 Model ICF Version 6.0dated 22-Feb-2011.

• HZCl13782_India_Dr. Polavarapu Veera Raghava Sarma _Telugu ICF_Version 3.0 _07 Apr 2011, Based on HZC113782 Model ICF Version 6.0dated 22-Feb-2011, Translated from English to Telugu on 08 September2011 -

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• HZC113782_India_Dr. Polavarapu Veera Raghava Sarma_Telugu to EnglishICF_ Version 3.0 _07 Apr 2011, Based on HZCl13782 Model ICF Version6.0 dated 22-Feb-2011, Back Translated from Telugu to English on 08September 2011

• Translation, Validation and Back translated certificates for all the translatedand back translated ICF's.

• Lung Function Questionnaire - English.

• HZC113782 mMRC (United States English) version Final date 27 Oct 2010.

• HZC113782 Medical problem Medications Taken Diary (US English)

template version Final date 27 Oct 2010.

• 110812 Brochure v1.0 United States (English) 290CT10.

• 110812 Dear Patient Letter v1.0 United States (English) 290CT10.

• 110812 Poster v1.0 United States (English) 290CT10.

• 110812 Print Ad v1.0 United States (English) 290CT10.

• 110812 Summit ID Card vOA United States (English) 03DEC10.

• 110812 Thank You Reminder Cardv1.0 United States (English) 290CT10.

• Lung Function Questionnaire_Telugu_date 17 January 2011",Based on Lung

Function Questionnaire_English_2008.

• HZC113782 mMRC (Telugu) version 1.0 Final date 17 January 2011, Based

on HZC113782 mMRC (United StatesEnglish) version Final date 27 Oct

2010.

• HZC113782 Medical problem Medications Taken Diary (Telugu) template

version 1.0 Final date 17 January 2011, Based on HZC113782 Medical

problem Medications Taken Diary (US .English) template version Final date

27 Oct 2010.

• 110812 Brochure v1.0 India (Telugu) 290CT10 ..

• 110812 Dear Patient Letter v1.0 India (Telugu) 290CT10.

• 110812 Poster v1.0 India (Telugu) 290CT10.

• 110812 Print Ad v1.0 India (Telugu) 290CT10.

• 110812 Summit ID Card vOA India (Telugu) 03DEC10.

• 110812 Thank You Reminder Card v1.0 India (Telugu) 290CT10

• Novel Dry Powder Inhaler usage instruction document; GlaxoSmithKline

R&D, Brentford, UK, English PU7703 SC146287.i

• 110812 Pictogram of Patient Token of Appreciation - Plastic Medication

Holder.

• Clinical Trial Compensation Guidelines; The Association of the British

Pharmace't.lticalIndustry. Issued January 1991, Reprinted March 1994.

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• Insu rance Certificate: Endorsement IssuePolicy Number: OG-11-1901-3306-00000008,01/01/2011, Policy Expiration Date: 31/12/2011

Date: 04.04.2011;Policy Effective Date:

• Clinical Trial Compensation Guidelines; The Association of the British

Pharmaceutical Industry. Issued January 1991, Reprinted March 1994,

Telugu.

• Safety Reports for the referenced study

• Line listing of INDSRs submitted between dates 01Apr2010 and 19Jan2011

inclusive.

• Investigator's Agreement with the Sponsor: Protocol number: HZC113782110812_India_Site Specific CSA_Dr. Polavarapu Veera Raghava SarmaEnglish_draft VO.1_ 03 Sep 2011 India_Inst_PI_CSA_direcCV2.5_English

• eCRF/CRF:SUMMIT Study; Blank CRFCasebook; Study Publish Date: 16-Mar-2011; Protocol: HZC113782; Study Version: 3.0.

• Investigator's undertaking dated Q-7-Sep-2011

• Investigator CV dated 08-Aug-2011.

• DCGI submission Acknowledgement letter dated S-May-2011.

At the Ethics Committee meeting held on 19-Jan-2012 your referenced letter and theabove documents were examined and discussed. After due consideration, thecommittee has decided to approve the conduct of the aforementioned study underyour direction at Lalitha Super Specialities Hospital (P) Ltd., Heart, Brain &.Multi Specialities, Kothapet, Guntur -522001, Andhra Pradesh, India as wellas all the study related documents.

The approval is subjected to following conditions:

1. Study can be initiated only after DCGI approval.

The Ethics Committee expects to be informed about the progress of the study, anySAE occurring in the course of the study, any change in the protocol and patientinformation/ informed consent and also let us have a periodic report on t,he progressof the study annually. . . -

We approve the assessment as specified in the protocol.

The following members of the Ethics Committee were present at themeeting held on 19-Jan-2012 at 19:00 hrs, in conference room of LalithaSuper Specialities Hospifal .

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Sr. Names of members Role in EC Designations GenderNo1 Dr. C. Nageswara Rao Chairman Retired Surgeon and Male

Ex- Chairman of APmedical Council

2 Dr. P. Vijaya Member Practicing Clinician FemaleSecretary

3 Mr. M.V.Subba Rao Legal Expert Lawyer Male4 Dr. E. Krishna Murthy Member Practicing Clinician Male5 Prof. Ramarao.Nadendla Pharmacologist Principal Male

Chalapathi Institute ofPharmaceuticalSciences

6 Mr. G.Y.N. Babu Social Worker Treasurer - Indian Red MaleCross Society

7 Mr. B. Adiseshaiah Member ' Retd. Sub Registrar Male8 Mrs. M. Nirmala Lay Person Retd. Lecturer Female

It is to be noted that neither you nor a,",y of your proposed study team memberswere present during the decision-making procedures of the Ethics Committee. Kindlynote that Dr.P.Vijaya (Wife of Dr.P.V. Raghava Sarma) was attended- the meeting butnot participated in the voting process.

The Ethics Committee works as per the guidelines of ICH-GCP, Schedule Y and allapplicable local regulatory requirements.

Yours truly,

C r ) 0 CL-?!//.Dr. C. Nageswara Rad .Chairman ~Lalitha specialities Hospital Ethics CommitteeKothapet, Guntur-522001.

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