To, Date: 17th Feb.2010

Dr. Anil Dhall,Director & Head of Cardiology,Artemis Health Institute,Sector-51, Gurgaon-122001,Haryana

Subject: Approval Letter.

Dear Dr. Dhall,

This is to inform you that the ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEWBOARD in its meeting held on os" Feb. 2010 at 15:00 at conference room, 2nd floor, Artemis Healthinstitute reviewed, discussed and unanimously agreed to approve the conduct of clinical trial entitled"Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure.A randomised double-blind placebo-controlled international multicentre study."

The following documents were reviewed.

Main Study1. Investigator's Brochure, version 11, dated 30 January 20092. Main study Protocol CL3-16257-083, dated 18 June 20093. Main study Protocol Signature Page (copy)4. Main study Patient Information and Consent Document, dated 18 June 2009, English version5. Main study Patient Information and Consent Document, (translated from English to Hindi)

dated 27 July 2009, Hindi version + translation certificate.6. Main study Patient Information and Consent Document (back translation Hindi to English),

dated 27 July 2009 + translation certificate7. Patient Cards, dated 24 June 2009, English version8. Patient Cards, (translated from English to Hindi) dated 25th July 2009, Hindi version +

translation certificate9. Patient Cards (back translated Hindi to English) dated 25th July 2009, English version +

translation certificate10. Signed and dated curriculum vitae (CV) of Principal Investigator (Dr. Ani! Dhall)II. QOL Protocol Signature Page (copy)12. QoL questionnaires(Hindi) + ENGLISH13. Protocol for QoL study, Final version, dated 30 June 200914. Patient Information and Consent document for QoL Study, English Version, dated so" June

200915. Patient Information and Consent document for QoL Study, Hindi version, dated 11th August,

2009 + translation certificate16. Patient Information and Consent document for QoL Study, English Version, (back translated

Hindi to English) dated 11th August 2009+ translation certificate17. QoL Assistance note dated 9th October 200918. QoL Assistance note dated 9th October 2009 (translated from English to Hindi)+ Validation

Certificate19. QoL Assistance note dated 9th October 2009 (back translated from Hindi to English)+

Validation Certificate20. QoL help note dated 9th October 200921. QoL help note dated 9th October 2009 (translated from English to Hindi) + Validation

Certificate22. QoL help note dated 9th October 2009 (back translated from Hindi to English) + Validation

Certificate23. Certificate ofInsurance

IPage 1 oE2

Artemis Medicare Services LimitedArtemis Health Institute. Sector 51. Gurgaon 122 00 I Haryana

Ph.: +91-124-6767999 Fax: +91-124-6767701 Emergency: +91-124-6767000 www.artemishospital.inRegistered Office: 414/ I. 4U,Floor. DDA Commercial Complex. District Centre. Janak Purl, New Delhi - I 10 058

24. DCGI submission acknowledgment Letter25. Draft Investigator Study Agreement26. Note on patient recruitment procedure27. eCRF Version 1.4 dated 191111200928. Investigator's Undertaking Form as per Appendix VII of Schedule Y29. Investigator list in India dated 18th September 0930. DCGI approval letter dated 03rd Feb.2010.

The following members attended the IRB meeting for the review of this clinical study. Thissatisfies the quorum necessary for such meetings of this IRB

S.No Name ofthe Member Gender Designation of themember

1 Mr. T.C.A. Male ChairpersonRangachari

2 Dr. R.K.Mani Male Vice-Chairperson

3 Dr. Deepak Govil Male IRB-Secretary

4. Dr. Reshma Basu Female Member

5. Mr. Pramod Kohli Male Legal Advisor

6 Mr. Dinesh Bhasin Male Lay person

7. Dr. Namita Jaggi Female Scientist

8. Ms. Kristen Female NGO representative

9 Mr. Himanshu Baweja Male Pharmacologist

We confirm that you did not participate in the deliberations of the IRB for this study and didnot vote on the proposal for this study.

We approve the protocol amendment to be executed in its presented form.

The ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD expects to beinformed about the progress of the study, any SAEs occurring in the course of the study, anychanges in the protocol and patient information/informed consent, protocol deviations, requestsannual study reports and asks to be provided a copy ofthe [mal report.

The ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD functions inaccordance with ICH and GCP guidelines and those laid down in the Ethical Guidelines forBiomedical Research on Human Subjects by Indian Council of Medical Research New Delhi.

,~f

Member Secretary, AHS- IRBArtemis Health Institute, Gurgoan.

I Artemis Medicare Ser1i~Iei1!1itedArtemis Health Institute. Sector 51. Gurgaon 122 00 I Haryana

Ph. : +91-124-6767999 Fax: +91-124-676770 I Emergency: +91-124-6767000 www.artemishospital.inRegistered Office: 414/ 1,4'" Floor, DDA Commercial Complex, District Centre, Janak Puri, New Delhi - I 10 058