Sosa, Saily
Bringas, Giosmany
Urrutia, Nelky
Peñalver, Ana Ivis
López, Danay
González, Evelio
Fernández, Ana
Hernández, Zenaida Milagros
Viña, Ariel
Peña, Yamile
Batista, Juan Felipe
Valenzuela, Carmen
León, Kalet
Crombet, Tania
Rodríguez, Teresita
Pérez, Leslie
Álvarez, Yolanda
Rodríguez, Madelín
Vázquez, Nairim
Rodríguez, Mirelys
González, Yaniuris
Ramos, María A.
López, Yosvany
Hernández, Mara
Madruga, Lázaro
Carmona, Dianelys
Acosta, Julio E.
López, Miriam
Amaro, Deiry
Baños, Olga L.
Álvarez, Mariela Ortega
Cordero, Anay
Betancourt, Melany
Padrón, Liana
Chávez, Elio
García, Isabel
Morgan, Yaquelin
Charles, Moraima
González, Mónica
de la C. Rodríguez, Marianela
León, Yeniley
López, Joe Michel
Acosta, Yanelis
de los Ángeles Virués, Trinidad
Pérez, Laura
León, Karen
Periche, Rubén
Valero, Adonisbel
Pozo, Yoelvis César
Horta, Greysi
Quesada, Rodobaldo
Luz, Elvia
Torres, Leonel A.
Romero, Susana
Rodríguez, María E.
Estévez, Daymys
,
Funding for this research was provided by:
Center of the Molecular Immunology (CIM), Havana, Cuba
Article History
Received: 24 August 2023
Accepted: 19 November 2023
First Online: 13 December 2023
Declarations
:
: The trial was conducted according to the International Conference on Harmonization Good Clinical Practice Guideline, the Declaration of Helsinki, and local regulatory requirements. An independent ethics committee/institutional review board at each site approved the study protocol. Participants and study partners provided written informed consent. The study was approved by Cuban Health Ministry (000010/2016) and Cuban Regulatory Agency (CECMED) (June 15, 2017). All data were kept confidential. Patient data were pseudo-anonymized, using a subject identification number which carried no information about the patient but could be referenced on a database with patient information if required.
: Not applicable.
: K. León, T. Crombet, T. Rodríguez and L. Pérez are employees of Center of Molecular Immunology, the institution that produces the Investigational New Drug (IND). T. Rodríguez is one of the authors of the patent “Human recombinant hyposialylated erythropoietin, methods of purification and therapeutic uses thereof” PCT US2022/0305084; no further authors have anything to disclose.