Updates are available Correction dated 2020-08-30
Click to view Correction: https://doi.org/10.1007/s13318-020-00638-0
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Authors
Conlan, Maureen G. http://orcid.org/0000-0002-0298-9866
de Vries, Erik F. J.
Glaudemans, AWJM
Wang, Yamei
Troy, Steven
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Funding
Funding for this research was provided by:
Radius Health, Inc.
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Article History
First Online: 13 July 2020
Change Date: 30 August 2020
Change Type: Correction
Change Details: Authors would like to correct the errors in table 2.
Compliance with Ethical Standards
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: This work was supported by Radius Health, Inc., on behalf of its wholly owned subsidiary, Radius Pharmaceuticals, Inc.
: EFJDV: received payment from Radius Health, Inc., for the execution and analysis of the PET scans. AWJMG: no competing interest. YW, ST and MGC are employees and stockholders of Radius Health, Inc.
: The clinical study protocols and informed consent forms were reviewed and approved by an independent ethics committee, and all subjects provided written informed consent. Both studies were conducted in accordance with the principles of the Declaration of Helsinki and in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products (CPMP) guideline CPMP/ICH/135/95), and with the EU CTD: Directive 2001/20/EC.
: All subjects were informed verbally and in writing of the objectives, procedures and risks of study participation including possible side effects and potential interactions. All participants signed the informed consent form before starting the studies.
: Data that underlie the results reported in a published article may be requested for further research 6 months after completion of FDA or EMA regulatory review of a marketing application or 18 months after trial completion (whichever is latest and/or if not associated with a marketing application). Radius will review requests individually to determine whether (1) the requests are legitimate and relevant and meet sound scientific research principles and (2) are within the scope of the participants’ informed consent. Prior to making data available, requestors will be required to agree in writing to certain obligations, including without limitation, compliance with applicable privacy and other laws and regulations. Proposals should be directed to info@radiuspharm.com.
