Inclusion criteria:  One of the following is required for inclusion into VTS301 Part C:  Has agreed to convert from the monthly dosing regimen used in the NIH phase 1/2a protocol to an every 2 weeks dosing regimen The investigator has received prior written authorization from the sponsor for the participant to enter VTS301 Part C on an amended dose and/or regimen Has received prior written authorization from Vtesse to enroll directly into Part C  Exclusion criteria:  None of the inclusion criteria are applicable