Povedano, Mónica
Paipa, Andrés
Barceló, Miquel
Woodward, Michael K.
Ortega, Sandra
Domínguez, Raúl
Aragonés, Maria Esperança
Horrillo, Raquel
Costa, Montserrat
Páez, Antonio
Article History
Received: 22 October 2020
Accepted: 16 July 2021
First Online: 18 November 2021
Declarations
:
: Standards for Good Clinical Practices (GCP) were adhered to for all procedures in this study. The investigators ensured that the study was conducted in full conformance with appropriate local laws and regulations and the Declaration of Helsinki. The protocol and protocol amendments were prepared in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines (and any other relevant regulations). The original protocol dated 15 Jan 2014 and the two subsequent protocol amendments and the Informed Consent Forms (ICF) were reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) of each participating research study centre prior to implementation.
: All participants provided written informed consent to participate.
: All authors have reviewed the manuscript and approved its publication in Neurological Sciences.
: Mónica Povedano, Andrés Paipa, Raúl Domínguez and Sandra Ortega report no conflicts of interest. Miquel Barceló, Michael K. Woodward, Maria Esperança Aragonés, Raquel Horrillo, Montserrat Costa and Antonio Páez are employees of Grifols, the manufacturer of Albutein®.