DMHC Ethics Committee Date: 26th October 2011

To, Dr. Venu Gopal Jhanwar Principal Investigator Deva Institute of Health Care & Research Pvt. Ltd. Durgakund, Varanasi - 221005 (U.P.)

Reference Study No.: 31-09-266: - A Long-term, Multicenter, Randomized, Double-blind, Placebo-centrolled study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia.

Subject: Approval of Study related Documents of the referenced study.

Dear Dr. Jhanwar, We have received from you 11 copies of the following document, with your letter dated: 17th October 2011.

~ Protocol 31-09-266, Amendment - 1, Version dated: 29 April 2011. ~ Investigator's Brochure Edition 14, Released 09 August 2010. ~ Investigator's Brochure Edition 14, Addendum version 1, dated: 24 November 2010. ~ Investigator's Brochure Edition 14, Addendum version 2, dated: 12 April 2011. ~ India Core English ICF Version 3.0, dated: 13 July 201 1. Site Specific English ICF, Dr.

Venu Gopal Jhanwar, Version 1.0, dated: 20 July 2011. ~ India Core English Assent, Version 3.0, dated: 13 July 2011. Site Specific English Assent

Dr. Venu Gopal Jhanwar, Version 1.0, dated: 20 July 2011. ~ Site Specific English ICF, Dr. Venu Gopal Jhanwar, Version 1.0, dated: 20 July 2011.

Hindi Site specific ICF, Dr. Venu Gopal Jhanwar, Version 2.0, dated: 17 August 2011. ~ Translation Certificate of Site Specific English ICF, Dr. Venu Gopal Jhanwar, Version

1.0, dated: 20 July 2011. Hindi Site Specific ICF, Dr, Venu Gopal Jhanwar, Version 2.0, dated: 17 August 2011.

y Site Specific English Assent, Dr. Venu Gopal Jhanwar, Version 1.0, dated: 20 July 2011. Hindi Site Specific Assent, Dr. Venu Gopal Jhanwar, Version 2.0, dated: 17 Aug 2011.

y Translation Certificate of Site Specific English Assent, Dr. Venu Gopal Jhanwar, Version 1.0, dated: 20 July 2011. Hindi Site Specific Assent, Dr. Venu Gopal Jhanwar, Version 2.0, dated: 17 August 2011 .

Patient Material in English: y Patient Emergency Card: USA_ENG_ 422_266_IDPD-02_vl-0_ 2010-11 -09. ~ Appointment Sticker: USA_ENG_ 422_266-267 _APPD-02_ vl-O_2010-05-27. y Appointment Sticker: USA_ENG_ 422_266-267 _APPD-03_vl-0_201O-05-27. Y Appointment Sticker: USA_ENG_ 422_266-267 _APPD-04_ vl-0_2010-05-27. Y Appointment Card: USA_ENG_ 422_266-267_APPD-Ol_vl-0_2010-05-27. > PQ-LE~-Q .

DMHC Ethics Committee 8 27/70 MN, 8adhal Kothi

Durgakund, Varanasi-5 (U.P.) INDIA Ph: +91-542-2313652/2310670

Fax: +91-542-2313748 E-mail: info@dmhcindia.com

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Patient Material in Hindi and Translation Certificates for the same:

~ Patient Emergency Card: IND_HIN_ 422_266_IDPD-02_vl-0_ 2010-11-09. ~ Appointment Sticker: IND _HIN_422_266-267 _APPD-02_ vl-0_2010-0S-27. ~ Appointment Sticker: IND_HIN_422_266-267_APPD-03_v1-0_2010-0S-27. ~ Appointment Sticker: IND_HIN_ 422_266-267 _APPD-04_v1-0_201O-0S-27. ~ Appointment Card: IND _HIN_422_266-267 _APPD-01_v1-0_2010-0S-27. • Insurance Certificate: dated: 01 September 2010 to 31 May 2014.

We received also one copy each of the following documents, with your submission letter dated: 17 October 2011: ­

• Investigator Undertaking dated: 12 October 2011. • P I MRC dated & CV, dated: 12 Oct 2011.

At the Ethics Committee Emergency Meeting held on 22 October 2011 , the above documents were reviewed, discussed and approved the study to be conducted in its present form.

Any update to the enclosed documents should be informed & approval should be sought from the Ethics Committee prior to their usage in the study.

The members, who attended this meeting, are listed below:

Qualification Designation at EC No. Sere Name

M.B.B.S. , M.D. , D.M. Prof. Dr. 1. P. Gupta Chairperson

(Gastro) 1.

Basic Medical Scientist

Dr. R. L. Agrawal M.B.B.S. , M.S. Secretary

(General Surgeon) 2.

Clinician

M.B.B.S. , M.D., D.G.O. 3. Prof. Dr. Amod Prakash Member (Gynec. & Obs.) Clinician

4. Dr. M. R. Jhan war M.B.B.S. , D.P.M. Member (Psychiatry) Clinician

S. Dr. V. P. Srivastava M.B.B.S. , D.P.M. Member (Psychiatry) Clinician

6. Mr. Anil Bajaj B.Com. L.L.B. Member; (Advocate) Legal Expert

7. Mrs. Reeta Gupta B.A., M.A. Member

Social Scientist

8. Mr. Manoj Shah B.E., M.B.A. Member

Lay person

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It is hereby confirmed that neither you nor any of the study team members have participated in the voting/decision making procedures of the committee.

This is to clarify that Dr. M. R. Jhanwar, did not participate in voting and decision making process in the meeting during the approval of the above referenced study and study related documents.

The DMHC Ethics Committee is ICH-GCP compliant.

Yours truly

QtL~ Dr. J. P. Gupta Chairperson, DMHC Ethics Committee

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