I spoke with the album's producer, producer, to get the inside scoop on the recording process, and which songs made it onto the final cut. The following interview has been edited for length and clarity.
December has been a busy month for Christmas music, with a genre-crossing portfolio featuring major stars, new artists and indie labels who've produced fresh holiday collections. Here are some of the best of the year.
But once Thanksgiving rolls around, the subject of holiday music usually takes a back seat to the real business of the season: food. Yes, turkey and stuffing and yams and chocolate chip cookies are the real highlights of the holidays, and we all know that the rest of the season is just an extended commercial for those items. In that respect, we can all take a break from holiday music, as long as we keep the music on in the background -- and if that's going to be the theme of your playlist, here's something to do to help you get your holiday fix.
The adverse event profile of nintedanib in the pooled population was consistent with that observed in the INPULSIS trials, with no new safety signals observed. The adverse event profile of nintedanib in the pooled population was generally manageable for most patients with IPF, with no new safety signals observed.
Exploratory analyses based on extrapolation of survival data suggested that patients with IPF who are treated with nintedanib have longer life expectancy than those who do not receive treatment.
We conducted this analysis according to a prespecified plan, and we did not change the analysis plan during the course of the study. The study protocol was not amended after the protocol was initially approved. We used a prespecified statistical analysis plan that did not allow for early stopping of the trial. Furthermore, the FDA approved the use of nintedanib for the treatment of IPF at the same time as the study was being conducted, further confirming that the safety and tolerability profile was unlikely to be affected by prespecified data monitoring. 827ec27edc