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StratosPHere 2: statistical analysis plan for a response-adaptive randomised placebo-controlled phase II trial to evaluate hydroxychloroquine and phenylbutyrate in pulmonary arterial hypertension caused by mutations in BMPR2

Crossref DOI link: https://doi.org/10.1186/s13063-025-08947-y

Published Online: 2025-07-11

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Das, Rajenki https://orcid.org/0000-0002-6225-4247
Deliu, Nina

Toshner, Mark R.

Villar, Sofía S.
Funding

Funding for this research was provided by:

Medical Research Council (MCUU00002/15)

Medical Research Council (MCUU00040/03)
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Text and Data Mining valid from 2025-07-11

Version of Record valid from 2025-07-11
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Article History

Received: 3 April 2025

Accepted: 23 June 2025

First Online: 11 July 2025

Declarations

:

: Ethical approval was gained from London Surrey Borders on date 12/09/2023. Written, informed consent will be obtained from all participants.

: Not applicable.

: MRT received support from NIHR Cambridge BRC and MRC. He received consulting fees for advisory roles by Jansen, Apollo Therapeutics and Merck, RxPx and uMEd, and travel support from GSK and Jansen. He has been member of the ComCov and FluCov data safety monitoring/advisory boards. SSV is member of the advisory board for PhaseV.

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