Table 1 Timing of standard assessments over the 3-year study

Clinic visit

X

X

Telephone contact

X

X

X

Informed consent/assent

X

Assess for eligibility

X

Medical and FOP history

X

Prior/concomitant medications

X

X

X

X

X

Post-baseline medical events

X

X

Physical examination

X

X

Linear height (≥ 18 years old)

X

X

Knee and sitting height (< 18 years old)

X

X

Body weight

X

X

Vital signs

X

X

Electrocardiogram

X

X

Pulmonary function tests

X

X

Pulse oximetry

X

X

Clinical laboratory assessments^a

X

X

Blood and urine for biomarkers samples^b

X

X

CAJIS

X

X

Knee and hand/wrist x-rays (< 18 years old)

X

WBCT (excluding head)

X

X

FOP assistive devices assessment

X

X

X

FOP-PFQ assessment

X

X

X

PROMIS Global Scales

X

X

X

Columbia-Suicide Severity Rating Scale

X

X

Genotyping

X

Adverse events

X

X

X

X