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Indian Phenotype Registry

NCT ID: NCT03363594

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-11

Study Completion Date

2019-06-14

Brief Summary

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This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

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Detailed Description

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This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

This is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Diabetes Mellitus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients with 18 years and above.
2. Patients who provide written informed consent.
3. Patients with previously diagnosed with Diabetes Mellitus
4. HbA1C report available within past 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Guntur, Andhra Pradesh, India

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Kākināda, Andhra Pradesh, India

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Madanapalle, Andhra Pradesh, India

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Nellore, Andhra Pradesh, India

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Rajahmundry, Andhra Pradesh, India

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Vijaywada, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Dibrugarh, Assam, India

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Guwahati, Assam, India

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Nagaon, Assam, India

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Silchar, Assam, India

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Tinsukia, Assam, India

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Bhagalpur, Bihar, India

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Gaya, Bihar, India

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Patna, Bihar, India

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Samāstipur, Bihar, India

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Samstipur, Bihar, India

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Bhilai, Chhattisgarh, India

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Durg, Chhattisgarh, India

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Raipur, Chhattisgarh, India

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Rohtak, Chhattisgarh, India

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Ahmedabad, Gujarat, India

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Amreli, Gujarat, India

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Anand, Gujarat, India

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Bharūch, Gujarat, India

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Bhavnagar, Gujarat, India

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Bhuj, Gujarat, India

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Borsad, Gujarat, India

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Botad, Gujarat, India

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Chaibasa, Gujarat, India

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Dohad, Gujarat, India

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Himatnagar, Gujarat, India

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Jamnagar, Gujarat, India

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Jūnāgadh, Gujarat, India

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Kutch, Gujarat, India

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Morvi, Gujarat, India

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Nadiād, Gujarat, India

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Navsari, Gujarat, India

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Pātan, Gujarat, India

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Porbandar, Gujarat, India

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Rajkot, Gujarat, India

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Surat, Gujarat, India

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Unnao, Gujarat, India

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Vadodara, Gujarat, India

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Valsād, Gujarat, India

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Vapi, Gujarat, India

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Bangalore, Haryana, India

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Faridabad, Haryana, India

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Gurugram, Haryana, India

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Hisar, Haryana, India

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Panchkula, Haryana, India

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Panipat, Haryana, India

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Rohtak, Haryana, India

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Sonīpat, Haryana, India

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Yamuna Nagar, Haryana, India

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Mandi, Himachal Pradesh, India

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Srinagar, Jammu and Kashmir, India

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Jamshedpur, Jharkhand, India

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Ranchi, Jharkhand, India

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Bangalore, Karnataka, India

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Belagavi, Karnataka, India

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Kalaburagi, Karnataka, India

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Angamaly, Kerala, India

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Chengannūr, Kerala, India

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Edappally, Kerala, India

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Ernākulam, Kerala, India

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Idukki, Kerala, India

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Kochi, Kerala, India

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Kollam, Kerala, India

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Kottayam, Kerala, India

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Malappuram, Kerala, India

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Nedumangād, Kerala, India

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Palakkad, Kerala, India

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Pezhakkappilly, Kerala, India

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Thalassery, Kerala, India

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Thiruvananthapuram, Kerala, India

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Thrissur, Kerala, India

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Trivandrum, Kerala, India

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Bhopal, Madhya Pradesh, India

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Guna, Madhya Pradesh, India

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Gwalior, Madhya Pradesh, India

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Indore, Madhya Pradesh, India

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Jabalpur, Madhya Pradesh, India

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Mandsaur, Madhya Pradesh, India

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Ujjain, Madhya Pradesh, India

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Ahilyanagar, Maharashtra, India

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Aurangabad, Maharashtra, India

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Bhiwandi, Maharashtra, India

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Kalyān, Maharashtra, India

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Kolhāpur, Maharashtra, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Navi Mumbai, Maharashtra, India

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Palanpur, Maharashtra, India

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Pālghar, Maharashtra, India

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Pune, Maharashtra, India

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Raigad, Maharashtra, India

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Rajkot, Maharashtra, India

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Sangli, Maharashtra, India

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Satara, Maharashtra, India

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Sindhudurg, Maharashtra, India

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Solapur, Maharashtra, India

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Thāne, Maharashtra, India

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Vasai, Maharashtra, India

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Imphal, Manipur, India

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Shillong, Meghālaya, India

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New Delhi, National Capital Territory of Delhi, India

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Berhampur, Odisha, India

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Bhubaneswar, Odisha, India

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Bhubneshwar, Odisha, India

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Bhuvaneshwar, Odisha, India

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Cuttack, Odisha, India

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Cuttuck, Odisha, India

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Paradip, Odisha, India

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Puri, Odisha, India

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Rourkela, Odisha, India

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Sambalpur, Odisha, India

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Amritsar, Punjab, India

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Jalandhar, Punjab, India

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Khanna, Punjab, India

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Kharar, Punjab, India

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Ludhiana, Punjab, India

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Moga, Punjab, India

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Patiāla, Punjab, India

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Ajmer, Rajasthan, India

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Ambala, Rajasthan, India

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Bikaner, Rajasthan, India

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Hanumāngarh, Rajasthan, India

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Jaipur, Rajasthan, India

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Jamshedpur, Rajasthan, India

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Jodhpur, Rajasthan, India

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Kota, Rajasthan, India

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Udaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Erode, Tamil Nadu, India

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Hosūr, Tamil Nadu, India

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Kanchipuram, Tamil Nadu, India

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Kochi, Tamil Nadu, India

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Kumbakonam, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Nagerkoil, Tamil Nadu, India

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Pattukkottai, Tamil Nadu, India

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Pondicherry, Tamil Nadu, India

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Ranipet, Tamil Nadu, India

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Salem, Tamil Nadu, India

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Thanjavur, Tamil Nadu, India

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Thiruvannamalai, Tamil Nadu, India

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Thiruvarur, Tamil Nadu, India

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Trichy, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Karīmnagar, Telangana, India

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Secunderabad, Telangana, India

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Agra, Uttar Pradesh, India

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Aligarh, Uttar Pradesh, India

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Allahābād, Uttar Pradesh, India

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Bareilly, Uttar Pradesh, India

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Bareli, Uttar Pradesh, India

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Bulandshahr, Uttar Pradesh, India

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Etāwah, Uttar Pradesh, India

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Faizabad, Uttar Pradesh, India

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Firozabad, Uttar Pradesh, India

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Ghaziabad, Uttar Pradesh, India

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Gorakhpur, Uttar Pradesh, India

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Hāthras, Uttar Pradesh, India

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Jhānsi, Uttar Pradesh, India

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Kanpur, Uttar Pradesh, India

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Karnal, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

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Meerut, Uttar Pradesh, India

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Morādābād, Uttar Pradesh, India

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Noida, Uttar Pradesh, India

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Piliphit, Uttar Pradesh, India

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Rāmpur, Uttar Pradesh, India

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Varanasi, Uttar Pradesh, India

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Dehradun, Uttarakhand, India

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Haldwani, Uttarakhand, India

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Baguihati, West Bengal, India

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Basīrhat, West Bengal, India

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Bolapur, West Bengal, India

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Burdwan, West Bengal, India

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Durgapur, West Bengal, India

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Guwahati, West Bengal, India

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Hābra, West Bengal, India

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Howrah, West Bengal, India

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Hubli, West Bengal, India

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Hugli, West Bengal, India

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Jalpāiguri, West Bengal, India

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Kharagpur, West Bengal, India

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Kolkata, West Bengal, India

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Malda, West Bengal, India

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Nabadwip, West Bengal, India

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Siliguri, West Bengal, India

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Chandigarh, , India

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Goa, , India

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Countries

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India

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1843R00282&attachmentIdentifier=f06144e6-5b1b-4200-bd96-e4315aaf6d57&fileName=D1843R00282_CSR_synopsis_redacted.pdf&versionIdentifier=

redacted CSR synopsis

Other Identifiers

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D1843R00282

Identifier Type: -

Identifier Source: org_study_id

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