Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Karem M Catasús-Álvarez, Odalys C Lazo-Diago, Cimara H Bermúdez-Badell, Pedro A López-Saura, Clinical Research Direction, Center for Genetic Engineering and Biotechnology, Havana 74110, Cuba
Georgina Castellanos-Sierra, Juan B. Zayas Hospital, Santiago de Cuba 90100, Cuba
Osmany Martínez-Serrano, Ernesto Guevara Hospital, Las Tunas 75100, Cuba
José R Causa-García, Celia Sánchez Hospital, Manzanillo, Granma 88000, Cuba
Juan E Domínguez-Suárez, Gustavo Aldereguía Hospital, Cienfuegos 55100, Cuba
Author contributions: Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM and López-Saura PA conceptualized and designed this study; Castellanos-Sierra G, Martínez-Serrano O, Causa-García JR and Domínguez-Suárez JE performed the clinical investigations and recruited/treated the majority of included patients; Hernandez-Bernal F, Catasús-Álvarez KM, Lazo-Diago OC and Bermúdez-Badell CH took part in trial coordination and monitoring; Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Catasús-Álvarez KM, Martínez-Serrano O, Lazo-Diago OC, Bermúdez-Badell CH, Causa-García JR and Domínguez-Suárez JE collected and managed the data; Valenzuela-Silva CM and López-Saura PA contributed to the statistical analyses; Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM and López-Saura PA analyzed and interpreted the data; Hernandez-Bernal F and López-Saura PA drafted the manuscript and gave final approval for the version to be published.
Supported by Heber Biotec, Havana (for providing products and reagents) and the Ministry of Public Health of Cuba (for hospital facilities and general medical care of patients).
Ethics approval: The study was reviewed and approved by the Ethics Committees of the participating hospitals and by the Cuban Regulatory Authority.
Clinical trial registration: This study is registered at http://registroclinico.sld.cu/. Cuban Public Clinical Trial Registry (Primary Registry of WHO). The registration identification number is RPCEC00000122.
Informed consent: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest: Hernández-Bernal F, Valenzuela-Silva CM, Catasús-Álvarez KM, Lazo-Diago OC, Bermúdez-Badell CH and López-Saura PA are employees of the Center for Genetic Engineering and Biotechnology, Havana Network, where rSK is produced and the new formulation was developed. The remaining authors have no conflict of interests. No honoraria, consulting fees, or payments for seminar presentations, speeches, or appearances have been received by any of the authors.
Data sharing: Technical appendix, statistical code, and dataset available from the corresponding author at email@example.com. Consent for data sharing was not obtained from participants, but the presented data are anonymized and risk of identification is null.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Francisco Hernández-Bernal, MD, MSc, Clinical Research Direction, Center for Genetic Engineering and Biotechnology, PO Box 6162, Havana 74110, Cuba. firstname.lastname@example.org
Telephone: +53-7-2087421 Fax: +53-7-2736008
Received: November 12, 2014
Peer-review started: November 15, 2014
First decision: December 26, 2014
Revised: January 10, 2015
Accepted: January 21, 2015
Article in press: January 21, 2015
Published online: June 21, 2015