Lothar Seefried, Jasmin Baumann, Sarah Hemsley, Christine Hofmann, Erdmute Kunstmann, Beate Kiese, Yue Huang, Simon Chivers, Marie-Anne Valentin, Babul Borah, Ronenn Roubenoff, Uwe Junker, Franz Jakob
Consolidated Standards of Reporting Trials (CONSORT) diagram.
A total of 9 patients were screened for the study. Only 8 patients were enrolled in the study, as 1 patient did not meet the study entry criteria. Of the 8 patients, 7 completed the study as per the protocol. One patient discontinued the study due to SAEs of angina pectoris and dyspnea. All patients who received the study drug were included in the safety analysis set; patients with evaluable pharmacokinetic (PK) parameter data were included in the PK analysis set; and patients with evaluable pharmacokinetic (PD) parameter data were included in the PD analysis set.