I suspect that after the initial enrollment for the OLE the loss of participants was a steady decline over time rather than a sudden withdrawal at one time.
Remember that most of the PDD trial participants and OLE participants came from Spain and that Spain was hit exceptionally hard by the COVID pandemic with over 13.7 million cases and over 119 thousand deaths due to the COVID pandemic. The Spanish heal care system was overwhelmed during the COVID pandemic.
Due to the COVID-19 pandemic, the start of the extension phase was delayed, on average, by approximately 41 weeks at the end of the preceding double-blind placebo-controlled study (DB). This led to a reduced enrollment rate for the extension phase. The period between the end of the double-blind phase to the start of the extension phase, where patients were not on ANAVEX®2-73 treatment, is known as a ‘drug holiday’. The drug holiday period of treatment separation provided an opportunity to compare the trajectory of clinical scores between no ANAVEX®2-73 treatment (drug holiday) and ANAVEX®2-73 treatment in the extension phase.
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