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Article History

Received: 29 July 2021

Accepted: 24 January 2022

First Online: 1 February 2022

Declarations

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: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants included in the study. This Phase III study was approved by the independent ethics committees including local independent committees at all participated study sites.<b>List of IRBs or IECs</b><b>Study Site # 01</b>Ethics Committee of Arkhangelsk Regional Clinical Cancer Dispensary, 145/1. Prospect Obvodniy Kanal, Arkhangelsk.Chairperson: Alexandra Yuryevna Pankratyeva.<b>Study Site # 03</b>Ethics Committee of State Healthcare Institution Tula Regional Cancer Dispensary, 16, Ul. Yablochkova, Tula, 300053.Chairperson: Svetlana Mikhailovna Kireeva.<b>Study Site # 05</b>Ethics Committee of State Budgetary Healthcare Institution Samara Regional Clinical Cancer Dispensary,50, Ul. Solnechnaya, Samaram, 443031.Chairperson: Tatyana Gennadyevna Zolotareva.<b>Study Site # 10</b>Ethics Committee of Federal State Budgetary Military Educational Institution of Higher Professional Education S.M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation,6, Ul. Akademika Lebedeva, Saint Petersburg, 194044.Chairperson: Sergey Borisovich Shustov.<b>Study Site # 11</b>Local Ethics Committee of Federal State Budgetary Institution N.N. Petrov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation,68, Ul. Leningradskaya, Pesochniy, Saint Petersburg, 197758.Chairperson: Evgeniy Vladimirovich Demin.<b>Study Site # 13</b>Ethics Committee of Moscow State Healthcare Institution Moscow City Oncology Hospital No. 62 of Healthcare Department of the City of Moscow,27, Bldg. 1-26, P.O. Stepanovskoye, Krasnogorsk District, Moscow Region, 143423.Chairperson: Svetlana Samoylovna Yudina.<b>Study Site # 14</b>Ethics Committee of State Budgetary Healthcare Institution Volgograd Regional Clinical Cancer Dispensary #1,78, Ul. Zemlyachki, Volgograd, 400138.Chairperson: Sergey Alexeevich Zhuravlev.<b>Study Site # 16</b>Ethics Committee of Federal State Budgetary Institution N.N. Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences,24, Kashirskoe shosse, Moscow, 115478.Chairperson: Dina Zurabovna Kupchyan.<b>Study Site # 18</b>Ethics Committee of State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Cancer Dispensary,42, Ul. Blykhera, Chelyabinsk, 454087.Chairperson: Alexey Valeryevich Privalov.<b>Study Site # 21</b>Ethics Committee of State Budgetary Healthcare Institution Perm Regional Cancer Dispensary, 15, Ul. Baumana, Perm, 614066.Chairperson: Yyuriiy Vladimirovich Kazakov.<b>Study Site # 22</b>Local Independent Ethics Committee of State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Hospital.70, Ul. Vorovskogo, Chelyabinsk, 454076.Chairperson: Vladimir Nikolaevich Kuzmin.<b>Study Site # 23</b>Local Ethics Committee of Regional Budgetary Healthcare Institution Kursk Regional Clinical Cancer Dispensary,20, Ul. Pirogova, Kursk, 305035.Chairperson: Vladimir Vladimirovich Khvostovoy.<b>Study Site # 24</b>Local Ethics Committee of State Budgetary Healthcare Institution Volgograd Regional Cancer Dispensary #3,25, Ul. Komsomolskaya, Volzhskiy, Volgograd Region, 404130.Chairperson: Viktoriya Viktorovna Zhavoronkova.<b>Study Site # 26</b>Local Ethics Committee of State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Cancer Dispensary, 31, Prospect Kalinina, Pyatigorsk, Stavropol Region, 357502.Chairperson: Liana Vasilyevna Zagorodnykh.<b>Study Site # 27</b>Ethics Committee Budgetary Healthcare Institution of Omsk Region Clinical Cancer Dispensary, 9/1. Ul. Zavertyaeva, Omsk, 644013.Chairperson: Oleg Vladimirovich Leonov.<b>Study Site # 29</b>Local Ethics Committee of State Budgetary Healthcare Institution Kursk Regional Cancer Dispensary of Healthcare Department of Kursk Region,20, Ul. Pirogova, Kursk, 305035.Chairperson: Vladimir Vladimirovich Khvostovoy.<b>Study Site # 30</b>Ethics Committee of State Autonomous Healthcare Institution Republican Clinical Cancer Dispensary of the Ministry of Healthcare of the Republic of Tatarstan,29, Ul. Sibirskiy Tract, Kazan, Republic of Tatarstan, 420029.Chairperson: Luiza Gaynutdinovna Karpenko.<b>Study Site # 34</b>Local Ethics Committee of Federal State Budgetary Educational Institution of Higher Professional Education N.P. Ogarev Mordovian State University,26 a, Ul. Ulyanova, Saransk, Republic of Mordovia, 430032.Chairperson: Natalya Viktorovna Shmyreva.<b>Study Site # 35</b>Local Ethics Committee of State Budgetary Healthcare Institution Orenburg Regional Clinical Cancer Dispensary,11, Prospect Gagarina, Orenburg, 460021.Chairperson: Alexander Gennadyevich Shekhtman.<b>Study Site # 36</b>Ethics Committee of State Budgetary Healthcare Institution of Higher Professional EducationI.P. Pavlov First Saint Petersburg State Medical University of the Ministry of Healthcare of the Russian Federation,10, Ul. Roentgena, Saint Petersburg, 197101.Chairperson: Edvin Eduardovich Zvartau.<b>Study Site # 43</b>Ethics Committee Shree HospitalShree Hospital, 5^th floor Siddharth Mansion,Nagar Road, Pune-411014, MaharashtraChairperson: Dr. Bhagwat Gunale<b>Study Site # 44</b>Ethics CommitteeBharath Hospital and Institute of Oncology# 438, Outer ring road, HebbalMysuru- 570017, KarnatakaChairperson: Dr. Majunath C<b>Study Site # 50</b>Ethics Committee of Healthcare Institution Brest Regional Clinical Cancer Dispensary,6, Ul. Meditsinskaya, Brest, Republic of Belarus, 224027.Chairperson: Vitaliy Nikolaevich Lemetskiy.<b>Study Site # 53</b>Yashoda Academy of Medical Education & Research8^th floor, Yashoda Hospitals, behind harihara kalabhavan,S P Road, Secunderabad-500003. Andhra PradeshChairperson: Justice Sri. V. Bhaskar Rao<b>Study Site # 55</b>Marudhar Hospital Ethics Committee,A-93-99, Basement, Singh bhoomi, Khatipura, Jaipur-302012,RajasthanChairperson: Ret. Col S. S. Rathore.<b>Study Site # 56</b>Institutional Ethics Committee Poona Medical Research FoundationE4-C to E4-F, 4^th Floor, Fifth Avenue Condominium,Dhole Patil Road, Pune-411001, MaharashtraChairperson: Lt. Gen (Dr) S A Cruze<b>Study Site # 57</b>Institutional Ethics Committee-Govt. Medical College, AurangabadPanchakki Road, Aurangabad-431001, Maharashtra.Chairperson: Dr S H Talib<b>Study Site # 58</b>Institutional Ethics Committee,All India Institute of Medical Sciences Bhubaneshwar,Sijua, Patrapada,Bhubaneshwar, Orissa,7510 19Chairperson: Dr. Suresh Chandra Dash<b>Study Site # 60</b>Shatabadi Hospital Ethics CommitteeC/o Shatabdi Superspeciality Hospital, G21,Suyoji City Centre, Opp. Mahamarg Bus Stand,Mumbai Naka, Nasik – 422002, MaharashtraChairperson: Dr. Neelima Shafekar,<b>Study Site # 62</b>Ethics Committee of Vinnytsa Regional Clinical Cancer Dispensary, 84, Ul. Khmelnitskoye sjosse, Vinnytsa, Ukraine.Chairperson: A.P. Kovalchuk<b>Study Site # 63</b>Ethics Committee of Zakarpattia Regional Clinical Cancer Dispensary, 2, Ul. Brodlokovicha, Uzhgorod, Ukraine.Chairperson: O.S. Chemet<b>Study Site # 65</b>Ethics Committee of Municipal Treatment and Preventive Facility City Cancer Dispensary, 107B, Ul. Kalinina, Donetsk, Ukraine.Chairperson: S.E. Bilousov<b>Study Site # 67</b>Institutional Ethics Committee,Rajalakshmi HospitalNo. 21/1. Lakshmipura main roadVidyaranyapura postBangalore, 560097, KarnatakaChairperson: Ms. Chnadana T J<b>Study Site # 68</b>Ethics Committee of Municipal Healthcare Institution Makeevka City Hospital No. 2 12, Ul. Ferganskaya, Makeevka, Donetsk Region, Ukraine.Chairperson: R.S. Titorenko<b>Study Site # 69</b>Ethics Committee of Municipal Institution Krivoy Rog Cancer Dispensary of Dnepropetrovsk Regional Council,41, Dnepropetrovskoye shosse, Krivoy Rog, Ukraine.Chairperson: O.V. Medvedkov<b>Study Site # 70</b>Ethics Committee of Municipal Healthcare Institution Kharkov Regional Clinical Cancer Center, 4, Ul. Lesoparkovaya, Kharkov, Ukraine.Chairperson: D.V. Shapovalov.<b>Study Site # 71</b>Institutional Ethics Committee,King George Medical University,Lucknow-226003. UPChairperson: Prof. S P S Gaur<b>Study Site # 72</b>Institutional Ethics Committee of SMS Medical College & attached Hospitals.Office of the Ethics Committee, Allergy clinic,SMS Hospital, JLN Marg,Jaipur-302004, RajasthanChairperson: Dr. Shashi Singhvi<b>Study Site # 74</b>Institutional Ethics Committee S P Medical College & AG of Hospital, Bikaner.Institutional Ethics Committee S P Medical College & AG of Hospital,HRM cardiovascular Science & Research, Bikaner-334001, RajasthanChairperson: Dr. G C Jain<b>Study Site # 76</b>HCG, Central Ethics Committee,HCG Tower, P. Kalinga Rao Road,Sampangirama Nagar Bangalore 560027, KarnatakaChairperson: Dr. S G A Rao<b>Study Site # 77</b>Institutional Ethics CommitteeSri Ramachandra Medical College and Research InstituteNo: 1, Ramachandra Nagar Porur, Chennai. 600116, Tamil NaduChairperson: Dr. Nalini Ramamurthy<b>Study Site # 78</b>MAHE Ethics CommitteeMezzanine floor, KMC Old Library Building,Madhava Nagar, Manipal-576104,Udupi Dist., KarnatakaChairperson: Dr. P. S Prakash<b>Study Site # 79</b>Institutional Ethics CommitteeMeenakshi Mission Hospital and Research CentreLake Area, Melur Road, Madurai-625107, Tamil NaduChairperson: Dr. Kumaresan<b>Study Site # 80</b>Institutional Ethics CommitteeHCG Curie City Cancer Center,# 44-1-1/3, Padavalarevu, Gunadala,Vijayawada- 520004 Andhra PradeshChairperson: Dr. V. N. N. Arun Kumar<b>Study Site # 81</b>Institutional Ethics Committee,Sapthagiri Institute of Medical Sciences and Research Center#15 Chikkasandra, Hesaraghatta Main road,Bangalore, Karnataka 560090Chairperson: Dr. Prasanna Kumar<b>Study Site # 83</b>Institutional Ethics Committee, KLE UniversityKLE University KLE Dr.PK Hospital and MRCNehru Nagar BelagaviKarnataka - 590010Chairperson: Dr. Subarna Roy<b>Study Site # 85</b>Institutional Ethics CommitteeNoble Hospital, Room No. 701No:4 Audiappa street, Alagappa road, Purasaiwakkam,Chennai- 600084, Tamil NaduChairperson: Dr. A. Vinoth Kumar<b>Study Site # 88</b>Institutional Ethics Committee,RG Kar Medical College & Hospital,1, Kshudiram Bose Sarani, Kolkata – 700004, West BengalChairperson: Dr. Krishnageshu Ray<b>Study Site # 89</b>IPGME & R Research Oversight Committee,Office of the dean,Institute of Post graduate Medical Education and Research,244 AJC Bose Road, Kolkata – 700020. West BengalChairperson: Dr Avijit Hazara.<b>Study Site # 90</b>Ethics Committee N.S.C.B.C Research InstituteNetaji Subhash Chandra Bose Cancer Hospital,3081, Nayabad, Kolkata-700094, West Bengal.Chairperson: Dr. M L. Chakraborty<b>Study Site # 91</b>Institutional Ethics Committee,NRS Medical College & Hospital,138, AJC Bose Road, Kolkata – 700014, West BengalChairperson: Prof (Dr). R. N Chattopadhyay<b>Study Site # 94</b>Institutional Ethics Committee of B. J. Govt. MedicalCollege & Sassoon General Hospital, Pune-411001, MaharashtraChairperson: Dr. Dayanand D. Shetty,<b>Study Site # 95</b>Ethics Committee Shalby Limited,Shalby Hospitals, Opp. Karnavati Club, S. G. Highway,Ahmedabad – 380015. GujaratChairperson: Dr. Guruprasad Dumra<b>Study Site # 96</b>Amravati Ethics Committee52/B, Shankar Nagar main road,Amravathi-444606, MaharashtraChairperson: Dr. S.S. Pande<b>Study Site # 97</b>Manavata Clinical Research Institute Ethics CommitteeCurie Manavata cancer centre,Opp. Mahamarg busstand, Mumbai naka, Nashik-422004, MaharashtraChairperson: Prof. Shantanu Kale<b>Study Site # 98</b>Institutional Ethics Committee- Clinical Studies,Site office Building,Apollo Hospitals International Ltd, Bhat,Gandhingar, Gujarat – 382428.Chairperson: Dr. Mira Desai

: Not applicable

: The authors declare that they have no competing interests.