Figures & data
Table 1. Concomitant medication protocols.
Table 2. Patient demographics and baseline characteristics.
Table 3. Summary of all-causality TEAEs through week 56 (treatment period).
Table 4. Summary of TEAEs of abnormal peripheral sensation through week 56 (treatment period).
Table 5. Summary of TEAEs of possible decreased sympathetic function through week 56 (treatment period).
Table 6. Summary of joint safety through week 80 (treatment + follow-up period).
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The authors certify that this manuscript reports original clinical trial data, NCT02725411. Upon request, and patient to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer and Lilly will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.