Parts 1, 2, 3 and 4
Patients must meet all the following criteria to be eligible to participate in the study:
Part 2
Patients must meet the following modified criterion to enter Part 2 of the study:
Part 3
Patients must meet the following additional and/or modified inclusion criteria to enter Part 3 of the study:
Part 4
Patients must meet the following additional and/or modified inclusion criteria to enter Part 4 of the study:
Patients who meet any one of the following criteria at baseline will be excluded from study participation:
o Concomitant with alkaline phosphatase > 2.5 times ULN (for Parts 3 and 4).
Part 2 For Part 2, there is no specific additional or modified exclusion criteria. Parts 3 & 4
For Parts 3 & 4, patients who meet any one of the following additional exclusion criteria at baseline will be excluded from study participation: