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• The programme had no planned sample size and no formal screening period.
• Expanded access was permitted by regulators in some but not all countries, and GSK did not solicit requests from physicians or participants.
• The Initial Compassionate Use Programme stopped in 2003 because of drug-supply limitations.
• Per-country enrolment figures were not collated.
• Local regulatory restrictions prevented clinical-database data collection for 28 participants, for whom only limited safety data were available.
• Eligibility criteria were revised repeatedly, including a 2009 restriction to life-threatening HES with documented failure of standard therapies.
• From May 2018, collection of efficacy, blood-eosinophil, and disease-control data ceased; only SAEs and physician-assessed mepolizumab-related non-serious AEs were required.
• Non-serious AEs considered unrelated to mepolizumab were incompletely collected, with under-reporting at some sites during the first three years and no required reporting after May 2018.
• Home dosing was introduced where appropriate in 2020 to improve access.
• No statistical analyses were performed because no hypotheses were defined.

These findings describe the trial, not the service provider’s performance or responsibility.